<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/NCT03817502</url>
  </required_header>
  <id_info>
    <org_study_id>RGH-MD-20</org_study_id>
    <secondary_id>2018-004006-26</secondary_id>
    <nct_id>NCT03817502</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia</brief_title>
  <official_title>A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gedeon Richter Plc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gedeon Richter Plc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of cariprazine in the&#xD;
      treatment of schizophrenia in the adolescent population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 6, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2025</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in PANSS total score at Week 6</measure>
    <time_frame>Baseline to Week 6</time_frame>
    <description>The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Cariprazine 1.5 mg/d</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cariprazine capsules, oral administration, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cariprazine 4.5 mg/d</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cariprazine capsules, oral administration, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo capsules, oral administration, once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cariprazine</intervention_name>
    <description>Cariprazine capsules, oral administration, once daily.</description>
    <arm_group_label>Cariprazine 1.5 mg/d</arm_group_label>
    <arm_group_label>Cariprazine 4.5 mg/d</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo capsules, oral administration, once daily.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-5 primary diagnosis of schizophrenia.&#xD;
&#xD;
          -  Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1)&#xD;
             by a trained clinician.&#xD;
&#xD;
          -  PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the&#xD;
             positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory&#xD;
             behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and&#xD;
             baseline (Visit 2).&#xD;
&#xD;
          -  CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit&#xD;
             2).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform&#xD;
             disorder, brief psychotic disorder, or psychotic disorder due to another medical&#xD;
             condition&#xD;
&#xD;
          -  Diagnosis of intellectual disability (IQ &lt; 70).&#xD;
&#xD;
          -  Participant has a history of meeting DSM-5 diagnosis for any substance-related&#xD;
             disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Balázs Lázár</last_name>
    <phone>+36 1 432 6437</phone>
    <email>RA.ctaRichter@richter.hu</email>
  </overall_contact>
  <location>
    <facility>
      <name>ProScience Research Group</name>
      <address>
        <city>Culver City</city>
        <state>California</state>
        <zip>90230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Atlanta Behavioral Research, LLC</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30338</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Bloomfield Hills MI</name>
      <address>
        <city>Bloomfield Hills</city>
        <state>Michigan</state>
        <zip>48302</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Precise Research Centers</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>UB Department of Psychiatry</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>142515</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Manhattan Behavioral Medicine PLLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Family Psychiatry of The Woodlands</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77381</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Clinic of Child Psychiatry St. Nikolas</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MHAT Targovishte</name>
      <address>
        <city>Targovishte</city>
        <zip>7700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.</name>
      <address>
        <city>Barranquilla</city>
        <zip>080020</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>E.S.E. Hospital Mental de Antioquia</name>
      <address>
        <city>Bello</city>
        <zip>051053</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion del Sitema Nervioso CISNE</name>
      <address>
        <city>Bogotá</city>
        <zip>1111666</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto Colombiano Sistema Nervioso Clinica Monserrat</name>
      <address>
        <city>Bogotá</city>
        <zip>250051</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Psynapsis Salud Mental SA</name>
      <address>
        <city>Pereira</city>
        <zip>660003</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro para la Medicina y de Asistencia Medica Especializada S.C.</name>
      <address>
        <city>Culiacán</city>
        <zip>80230</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigacion Clinica AC</name>
      <address>
        <city>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Consultorio de Medicina Especializada del Sector Privado</name>
      <address>
        <city>Guadalajara</city>
        <zip>44690</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra</name>
      <address>
        <city>Guanajuato</city>
        <zip>37000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Iecsi S.C.</name>
      <address>
        <city>Monterrey</city>
        <zip>64310</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CIT Neuropsique</name>
      <address>
        <city>Monterrey</city>
        <zip>64610</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto de Informacion e Investigacion en Salud Mental AC</name>
      <address>
        <city>Monterrey</city>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medical Care and Research S.A. de C.V.</name>
      <address>
        <city>Mérida</city>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>BLIND Investigaciones SC</name>
      <address>
        <city>San Luis Potosí</city>
        <zip>78213</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Socola Psychiatric Institute Iasi</name>
      <address>
        <city>Iaşi</city>
        <zip>700282</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti</name>
      <address>
        <city>Timişoara</city>
        <zip>300230</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>State Institution of Healthcare &quot;Arkhangelsk Regional Clinical Psychiatric Hospital&quot;</name>
      <address>
        <city>Arkhangel'sk</city>
        <zip>163530</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Kazan State Medical University KSMU</name>
      <address>
        <city>Kazan</city>
        <zip>420012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>SBHI Specialized Clinical Psychiatric Hospital 1</name>
      <address>
        <city>Krasnodar</city>
        <zip>350007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Regional Public Institution &quot;Lipetsk Regional Psychoneurological Hospital&quot;</name>
      <address>
        <city>Lipetsk</city>
        <zip>399083</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Joint-Stock Company Scientific Centre of Personalized Medicine</name>
      <address>
        <city>Moscow</city>
        <zip>105082</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>SBHI of Moscow Region &quot;Central Clinical Psychiatric Hospital&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>127083</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Clinical Psychiatry Hospital #1 of Nizhniy Novgorod</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603155</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary</name>
      <address>
        <city>Roshchino</city>
        <zip>188820</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>190121</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev&quot; of the Ministry of Healthcare of the Russian Federation</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>192019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Center for Medical Rehabilitation named after S.S. Mnukhin</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>GBUZ Samara Regional Clinical Psychiatric Hospital</name>
      <address>
        <city>Samara</city>
        <zip>443016</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution &quot;Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky&quot;</name>
      <address>
        <city>Saratov</city>
        <zip>410028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Smolensk State Medical University</name>
      <address>
        <city>Smolensk</city>
        <zip>214019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>LLC Podderzhka</name>
      <address>
        <city>Stavropol</city>
        <zip>355038</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>LLC Clinic &quot;Sto Let&quot;</name>
      <address>
        <city>Tomsk</city>
        <zip>634014</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Stavropol Regional Psychiatric hospital #2</name>
      <address>
        <city>Tonnel'nyy</city>
        <zip>357034</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Yaroslavl Regional Psychiatric Hospital</name>
      <address>
        <city>Yaroslavl Region</city>
        <zip>634009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Clinic.Neuro.Psych.Child.Youth</name>
      <address>
        <city>Belgrad</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institute for Mental Health</name>
      <address>
        <city>Belgrad</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinic for psychiatry, KCV</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Regional Psychonevrological Hospital #3</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>SI &quot;Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine&quot;</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>State Institution &quot;Institute of Health Care for Children and Adolescents of the AMS of Ukraine</name>
      <address>
        <city>Kharkov</city>
        <zip>61153</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Kherson Regional Institution of Mental Care</name>
      <address>
        <city>Kherson</city>
        <zip>73488</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>SI Research Institute of Psychiatry of MoH of Ukraine</name>
      <address>
        <city>Kyiv</city>
        <zip>04108</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital</name>
      <address>
        <city>Lviv</city>
        <zip>79021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Odesa Regional Medical Centre of Mental Health</name>
      <address>
        <city>Odesa</city>
        <zip>65006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Municipal Institution &quot;Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko&quot;</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Colombia</country>
    <country>Mexico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Cariprazine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Gedeon Richter will share de-identified patient-level data and study-level data for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. For more information please contact ra.ctarichter@richter.hu.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.</ipd_time_frame>
    <ipd_access_criteria>To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03817502
org study id: RGH-MD-20
secondary id: 2018-004006-26
nct id: NCT03817502
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the
      treatment of schizophrenia in the adolescent population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in PANSS total score at Week 6
time frame: Baseline to Week 6
description: The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.
arm group label: Cariprazine 1.5 mg/d
arm group type: Experimental
description: Cariprazine capsules, oral administration, once daily.
arm group label: Cariprazine 4.5 mg/d
arm group type: Experimental
description: Cariprazine capsules, oral administration, once daily.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo capsules, oral administration, once daily.
intervention type: Drug
intervention name: Cariprazine
description: Cariprazine capsules, oral administration, once daily.
arm group label: Cariprazine 1.5 mg/d
arm group label: Cariprazine 4.5 mg/d
intervention type: Drug
intervention name: Placebo
description: Matching placebo capsules, oral administration, once daily.
arm group label: Placebo
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
last name: Balázs Lázár
phone: +36 1 432 6437
email: RA.ctaRichter@richter.hu
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Suspended
facility: 
status: Withdrawn
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Withdrawn
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Terminated
facility: 
status: Withdrawn
country: Bulgaria
country: Colombia
country: Mexico
country: Romania
country: Russian Federation
country: Serbia
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Cariprazine
sharing ipd: Yes
ipd description: Gedeon Richter will share de-identified patient-level data and study-level data for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. For more information please contact ra.ctarichter@richter.hu.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
ipd access criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.