<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/NCT01724372</url>
  </required_header>
  <id_info>
    <org_study_id>12-094</org_study_id>
    <nct_id>NCT01724372</nct_id>
  </id_info>
  <brief_title>The Role of Antidepressants or Antipsychotics in Preventing Psychosis</brief_title>
  <official_title>The Role of Antidepressants or Antipsychotics in Preventing Psychosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Luke's-Roosevelt Hospital Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Zucker Hillside Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Luke's-Roosevelt Hospital Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the&#xD;
      second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk&#xD;
      for developing psychosis.&#xD;
&#xD;
      Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated&#xD;
      and will lead to greater improvement in symptoms at the end of 6 months of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">May 2014</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attenuated positive, negative and general psychiatric symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Social and role functioning</measure>
    <time_frame>6 months</time_frame>
    <description>To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to all-cause discontinuation.</measure>
    <time_frame>6 months</time_frame>
    <description>To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>6 months</time_frame>
    <description>To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Psychotic Disorder</condition>
  <arm_group>
    <arm_group_label>Antidepressant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluoxetine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antipsychotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aripiprazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antidepressant</intervention_name>
    <arm_group_label>Antidepressant</arm_group_label>
    <other_name>Fluoxetine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antipsychotic</intervention_name>
    <arm_group_label>Antipsychotic</arm_group_label>
    <other_name>Aripiprazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12-25 years of age (inclusive)&#xD;
&#xD;
          -  Able to understand and speak English&#xD;
&#xD;
          -  Have at least one sub-threshold positive psychotic symptom that is moderate,&#xD;
             moderately severe, or severe&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder;&#xD;
             schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with&#xD;
             psychotic features&#xD;
&#xD;
          -  Current psychosis&#xD;
&#xD;
          -  Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe&#xD;
             without psychotic features&#xD;
&#xD;
          -  Lifetime diagnosis of substance abuse or dependence (excluding nicotine)&#xD;
&#xD;
          -  Current stimulant treatment&#xD;
&#xD;
          -  Any significant medical condition that contra-indicates treatment with either&#xD;
             aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other&#xD;
             medical condition known to affect the brain&#xD;
&#xD;
          -  Estimated intelligence quotient &lt; 70&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>May 23, 2014</last_update_submitted>
  <last_update_submitted_qc>May 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 26, 2014</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>Psychotic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aripiprazole</mesh_term>
    <mesh_term>Antipsychotic Agents</mesh_term>
    <mesh_term>Fluoxetine</mesh_term>
    <mesh_term>Antidepressive Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01724372
org study id: 12-094
nct id: NCT01724372
lead sponsor: 
collaborator: 
has dmc: No
This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the
      second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk
      for developing psychosis.

      Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated
      and will lead to greater improvement in symptoms at the end of 6 months of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Attenuated positive, negative and general psychiatric symptoms
time frame: 6 months
description: To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.
measure: Social and role functioning
time frame: 6 months
description: To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.
measure: Time to all-cause discontinuation.
time frame: 6 months
description: To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.
measure: Adverse effects
time frame: 6 months
description: To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.
arm group label: Antidepressant
arm group type: Experimental
description: Fluoxetine
arm group label: Antipsychotic
arm group type: Active Comparator
description: Aripiprazole
intervention type: Drug
intervention name: Antidepressant
arm group label: Antidepressant
other name: Fluoxetine
intervention type: Drug
intervention name: Antipsychotic
arm group label: Antipsychotic
other name: Aripiprazole
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: No
country: United States
responsible party type: Sponsor
mesh term: Psychotic Disorders
mesh term: Aripiprazole
mesh term: Antipsychotic Agents
mesh term: Fluoxetine
mesh term: Antidepressive Agents