<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01663532</url>
  </required_header>
  <id_info>
    <org_study_id>31-12-291</org_study_id>
    <nct_id>NCT01663532</nct_id>
  </id_info>
  <brief_title>Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia</brief_title>
  <official_title>A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Otsuka America Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to evaluate the overall efficacy of aripiprazole&#xD;
      intramuscular (IM) depot as acute treatment in subjects with schizophrenia.&#xD;
&#xD;
      The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot&#xD;
      administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.</measure>
    <time_frame>Baseline to Week 10</time_frame>
    <description>The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.</measure>
    <time_frame>Baseline to Week 10</time_frame>
    <description>The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: &quot;Considering your total experience with this particular population, how mentally ill is the patient at this time?&quot; Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.</measure>
    <time_frame>Baseline to Week 10</time_frame>
    <description>The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.</measure>
    <time_frame>Baseline to Week 10</time_frame>
    <description>The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.</measure>
    <time_frame>Week 10</time_frame>
    <description>The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.</measure>
    <time_frame>Week 10</time_frame>
    <description>The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: &quot;Considering your total experience with this particular population, how mentally ill is the patient at this time?&quot; Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder Rate Based on PANSS Total Score.</measure>
    <time_frame>Week 10</time_frame>
    <description>Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">340</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Aripiprazole IM Depot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aripiprazole IM Depot 400 mg, with allowed decrease to 300 mg for safety and return to 400 mg for efficacy if needed, every four weeks for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aripiprazole IM Depot</intervention_name>
    <arm_group_label>Aripiprazole IM Depot</arm_group_label>
    <other_name>OPC-14597</other_name>
    <other_name>Lu AF41155</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects 18 to 65 years of age, inclusive, at time of informed&#xD;
             consent.&#xD;
&#xD;
          -  Subjects with a diagnosis of schizophrenia for at least 1 year as defined by DSM-IV-TR&#xD;
             criteria and confirmed by the MINI for Schizophrenia and Psychotic Disorders Studies.&#xD;
&#xD;
          -  Subjects with a stable living environment when not in hospital.&#xD;
&#xD;
          -  Subjects who would benefit from hospitalization or continued hospitalization for&#xD;
             treatment of a current acute relapse of schizophrenia at trial entry.&#xD;
&#xD;
          -  Subjects who are experiencing an acute exacerbation of psychotic symptoms and marked&#xD;
             deterioration of usual function as demonstrated by meeting BOTH of the following at&#xD;
             screening and baseline:&#xD;
&#xD;
               -  Currently experiencing an acute exacerbation of psychotic symptoms accompanied by&#xD;
                  significant deterioration in the subject's clinical and/or functional status from&#xD;
                  their baseline clinical presentation with a Positive and Negative Syndrome Scale&#xD;
                  (PANSS) Total Score ≥ 80 AND&#xD;
&#xD;
               -  Specific psychotic symptoms on the PANSS as measured by a score of &gt; 4 on each of&#xD;
                  the following items (possible scores of 1 to 7 for each item)&#xD;
&#xD;
                    -  Conceptual disorganization (P2)&#xD;
&#xD;
                    -  Hallucinatory behavior (P3)&#xD;
&#xD;
                    -  Suspiciousness/persecution (P6)&#xD;
&#xD;
                    -  Unusual thought content (G9)&#xD;
&#xD;
          -  Subjects who have received previous outpatient antipsychotic treatment at an adequate&#xD;
             dose for an adequate duration and who showed a previous good response to such&#xD;
             antipsychotic treatment (other than clozapine) in last 12 months.&#xD;
&#xD;
          -  Subjects with a history of relapse and/or exacerbation of symptoms when not receiving&#xD;
             antipsychotic treatment, excluding current episode.&#xD;
&#xD;
          -  Subjects willing to discontinue all prohibited psychotropic medications to meet&#xD;
             protocol required washouts prior to and during trial period.&#xD;
&#xD;
          -  BMI less ≤ 40 kg/m2 (morbid obesity) at screening.&#xD;
&#xD;
          -  Subjects who are able to provide written informed consent.&#xD;
&#xD;
          -  Ability to understand the nature of trial and follow protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sexually active males of childbearing potential who do not agree to practice 2&#xD;
             different methods of birth control or remain abstinent during the trial and for 180&#xD;
             days after last dose of trial medication. Sexually active females of childbearing&#xD;
             potential who do not agree to practice 2 different methods of birth control or remain&#xD;
             abstinent during the trial and for 150 days after last dose of trial medication.&#xD;
&#xD;
          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior&#xD;
             to receiving IMP in this trial.&#xD;
&#xD;
          -  Subjects with improvement of ≥ 30% in total PANSS score between the screening and&#xD;
             baseline assessments. - Subjects presenting with a first episode of schizophrenia -&#xD;
             Subjects hospitalized for ≥ 30 days out of the last 90 days prior to screening visit.&#xD;
             Subjects who have been hospitalized &gt; 5 days for current acute episode at the time of&#xD;
             screening visit&#xD;
&#xD;
          -  Subjects with schizophrenia who are considered resistant/refractory to antipsychotic&#xD;
             treatment Subjects who have a history of response to clozapine treatment only.&#xD;
&#xD;
          -  Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia Also,&#xD;
             subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial&#xD;
             personality disorder or mental retardation.&#xD;
&#xD;
          -  Subjects experiencing acute depressive symptoms within past 30 days that require&#xD;
             treatment with an antidepressant.&#xD;
&#xD;
          -  Subjects with a significant risk of violent behavior; who represent a risk of&#xD;
             committing suicide as indicated by any suicidal ideation within the last 1 month or&#xD;
             any suicidal behaviors within the last year; or who present a serious risk of suicide.&#xD;
&#xD;
          -  Subjects with clinically significant tardive dyskinesia,.&#xD;
&#xD;
          -  Subjects with severe akathisia.&#xD;
&#xD;
          -  Subjects who have met DSM-IV-TR criteria for substance abuse with past 3 months prior&#xD;
             to screening or dependence within past 6 months; including alcohol and&#xD;
             benzodiazepines, but excluding caffeine and nicotine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>72764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Carson</city>
        <state>California</state>
        <zip>90746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>National City</city>
        <state>California</state>
        <zip>91950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pico Rivera</city>
        <state>California</state>
        <zip>90660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ft. Lauderdale</city>
        <state>Florida</state>
        <zip>33301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ft. Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ft. Lauderdale</city>
        <state>Florida</state>
        <zip>33334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hoffman Estates</city>
        <state>Illinois</state>
        <zip>60169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Charles</city>
        <state>Missouri</state>
        <zip>63304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Holliswood</city>
        <state>New York</state>
        <zip>11423</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78754</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Popovaca</city>
        <zip>44317</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zagreb</city>
        <zip>10090</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5417</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jelgava</city>
        <zip>LV-3008</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liepaja</city>
        <zip>LV-3401</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Strenci</city>
        <zip>LV-4730</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
    <country>Latvia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>December 19, 2014</results_first_submitted>
  <results_first_submitted_qc>February 12, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 16, 2015</results_first_posted>
  <disposition_first_submitted>October 10, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>October 10, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 20, 2014</disposition_first_posted>
  <last_update_submitted>February 12, 2015</last_update_submitted>
  <last_update_submitted_qc>February 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aripiprazole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of aripiprazole IM (intramuscular) depot as treatment for an acute episode of schizophrenia in adult participants. The trial was conducted in 55 sites.</recruitment_details>
      <pre_assignment_details>This trial included a 13-Day Screening phase (which includes Washout from previous antipsychotics for 7 days and/or washout from other prohibited medications), a 12-Week acute treatment phase, and a 14 (±2) Day safety follow-up.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Aripiprazole IM Depot 400/300mg</title>
          <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="168"/>
                <participants group_id="P2" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Met Withdrawal Criteria</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Aripiprazole IM Depot 400/300mg</title>
          <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="168"/>
            <count group_id="B2" value="172"/>
            <count group_id="B3" value="340"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.1" spread="11.0"/>
                    <measurement group_id="B2" value="42.7" spread="10.9"/>
                    <measurement group_id="B3" value="42.4" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.</title>
        <description>The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.</description>
        <time_frame>Baseline to Week 10</time_frame>
        <population>Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole IM Depot 400/300mg</title>
            <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.</title>
          <description>The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.</description>
          <population>Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (N= 162, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.9" spread="0.9"/>
                    <measurement group_id="O2" value="-5.0" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (N= 144, 157)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.2" spread="1.2"/>
                    <measurement group_id="O2" value="-8.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (N= 134, 140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.0" spread="1.4"/>
                    <measurement group_id="O2" value="-9.8" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (N= 126, 117)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.5" spread="1.5"/>
                    <measurement group_id="O2" value="-10.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (N= 108, 96)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.7" spread="1.6"/>
                    <measurement group_id="O2" value="-9.7" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (N= 99, 81)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.8" spread="1.6"/>
                    <measurement group_id="O2" value="-11.7" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0005</p_value>
            <p_value_desc>Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.1</ci_lower_limit>
            <ci_upper_limit>-1.7</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.0</ci_lower_limit>
            <ci_upper_limit>-4.0</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-9.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.8</ci_lower_limit>
            <ci_upper_limit>-5.6</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at week 4.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.0</ci_lower_limit>
            <ci_upper_limit>-7.3</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-14.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.4</ci_lower_limit>
            <ci_upper_limit>-9.6</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-15.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.4</ci_lower_limit>
            <ci_upper_limit>-10.8</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.</title>
        <description>The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: &quot;Considering your total experience with this particular population, how mentally ill is the patient at this time?&quot; Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.</description>
        <time_frame>Baseline to Week 10</time_frame>
        <population>Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 168 participants from aripiprazole and placebo groups were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole IM Depot 400/300mg</title>
            <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.</title>
          <description>The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: &quot;Considering your total experience with this particular population, how mentally ill is the patient at this time?&quot; Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.</description>
          <population>Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 168 participants from aripiprazole and placebo groups were available.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (N= 162, 168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="0.1"/>
                    <measurement group_id="O2" value="-0.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (N= 144, 157)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.1"/>
                    <measurement group_id="O2" value="-0.4" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (N= 134, 140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="0.1"/>
                    <measurement group_id="O2" value="-0.4" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (N= 126, 117)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="0.1"/>
                    <measurement group_id="O2" value="-0.5" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (N= 108, 96)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="0.1"/>
                    <measurement group_id="O2" value="-0.6" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (N= 99, 81)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="0.1"/>
                    <measurement group_id="O2" value="-0.6" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <p_value_desc>After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>-0.6</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.</title>
        <description>The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).</description>
        <time_frame>Baseline to Week 10</time_frame>
        <population>Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole IM Depot 400/300mg</title>
            <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.</title>
          <description>The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).</description>
          <population>Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (N= 162, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="0.3"/>
                    <measurement group_id="O2" value="-2.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (N= 144, 157)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.7" spread="0.4"/>
                    <measurement group_id="O2" value="-3.4" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (N= 134, 140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="0.5"/>
                    <measurement group_id="O2" value="-3.9" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (N= 126, 117)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.2" spread="0.5"/>
                    <measurement group_id="O2" value="-4.4" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (N= 108, 96)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.9" spread="0.5"/>
                    <measurement group_id="O2" value="-4.1" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (N= 99, 81)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.0" spread="0.5"/>
                    <measurement group_id="O2" value="-4.9" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>-0.6</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>-1.3</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>-2.0</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.1</ci_lower_limit>
            <ci_upper_limit>-2.6</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.2</ci_lower_limit>
            <ci_upper_limit>-3.4</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.4</ci_lower_limit>
            <ci_upper_limit>-3.7</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.</title>
        <description>The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).</description>
        <time_frame>Baseline to Week 10</time_frame>
        <population>Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole IM Depot 400/300mg</title>
            <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.</title>
          <description>The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).</description>
          <population>Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (N= 162, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="0.2"/>
                    <measurement group_id="O2" value="-0.7" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (N= 144, 157)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="0.3"/>
                    <measurement group_id="O2" value="-1.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (N= 134, 140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="0.4"/>
                    <measurement group_id="O2" value="-1.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (N= 126, 117)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="0.4"/>
                    <measurement group_id="O2" value="-1.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (N= 108, 96)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="0.4"/>
                    <measurement group_id="O2" value="-1.4" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (N= 99, 81)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="0.5"/>
                    <measurement group_id="O2" value="-1.6" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0023</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0032</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.2</ci_lower_limit>
            <ci_upper_limit>-1.3</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>-1.4</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.1</ci_lower_limit>
            <ci_upper_limit>-1.6</ci_upper_limit>
            <estimate_desc>Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.</title>
        <description>The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.</description>
        <time_frame>Week 10</time_frame>
        <population>Efficacy sample included participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole IM Depot 400/300mg</title>
            <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.</title>
          <description>The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.</description>
          <population>Efficacy sample included participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
                <count group_id="O2" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="1.2"/>
                    <measurement group_id="O2" value="5.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Week 10.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment and pooled centers as factors and Baseline value as covariate for the comparison at other visits.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.1</ci_lower_limit>
            <ci_upper_limit>10.1</ci_upper_limit>
            <estimate_desc>Difference in least square mean of change were derived from ANCOVA model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.</title>
        <description>The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: &quot;Considering your total experience with this particular population, how mentally ill is the patient at this time?&quot; Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.</description>
        <time_frame>Week 10</time_frame>
        <population>Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole IM Depot 400/300mg</title>
            <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.</title>
          <description>The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: &quot;Considering your total experience with this particular population, how mentally ill is the patient at this time?&quot; Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.</description>
          <population>Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.2"/>
                    <measurement group_id="O2" value="3.7" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Week 10. LOCF method were used in imputation of missing data.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>CMH raw mean scores differ test (Van Elteren test) controlling for pooled centers.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Responder Rate Based on PANSS Total Score.</title>
        <description>Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).</description>
        <time_frame>Week 10</time_frame>
        <population>Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole IM Depot 400/300mg</title>
            <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Responder Rate Based on PANSS Total Score.</title>
          <description>Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).</description>
          <population>Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Week 10. LOCF method were used in imputation of missing data.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>CMH test controlling by region (pooled sites).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>22.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.9</ci_lower_limit>
            <ci_upper_limit>32.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.</time_frame>
      <desc>One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.</desc>
      <group_list>
        <group group_id="E1">
          <title>Aripiprazole IM Depot 400/300mg</title>
          <description>Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Substance abuse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="167"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Affairs</name_or_title>
      <organization>Otsuka Pharmaceutical Development and Commercialization, Inc.</organization>
      <phone>800 562-3974</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01663532
org study id: 31-12-291
nct id: NCT01663532
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The primary purpose of this study is to evaluate the overall efficacy of aripiprazole
      intramuscular (IM) depot as acute treatment in subjects with schizophrenia.

      The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot
      administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
time frame: Baseline to Week 10
description: The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.
measure: Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
time frame: Baseline to Week 10
description: The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: "Considering your total experience with this particular population, how mentally ill is the patient at this time?" Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.
measure: Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
time frame: Baseline to Week 10
description: The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
measure: Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
time frame: Baseline to Week 10
description: The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
measure: Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.
time frame: Week 10
description: The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
measure: Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.
time frame: Week 10
description: The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: "Considering your total experience with this particular population, how mentally ill is the patient at this time?" Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.
measure: Responder Rate Based on PANSS Total Score.
time frame: Week 10
description: Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
arm group label: Aripiprazole IM Depot
arm group type: Experimental
description: Aripiprazole IM Depot 400 mg, with allowed decrease to 300 mg for safety and return to 400 mg for efficacy if needed, every four weeks for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo
intervention type: Drug
intervention name: Aripiprazole IM Depot
arm group label: Aripiprazole IM Depot
other name: OPC-14597
other name: Lu AF41155
intervention type: Drug
intervention name: Placebo
description: Matching Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Croatia
country: Latvia
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Aripiprazole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 