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The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Primary Purpose

Psychotic Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antidepressant
Antipsychotic
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorder

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 12-25 years of age (inclusive)
  • Able to understand and speak English
  • Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe

Exclusion Criteria:

  • Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features
  • Current psychosis
  • Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features
  • Lifetime diagnosis of substance abuse or dependence (excluding nicotine)
  • Current stimulant treatment
  • Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain
  • Estimated intelligence quotient < 70

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Antidepressant

    Antipsychotic

    Arm Description

    Fluoxetine

    Aripiprazole

    Outcomes

    Primary Outcome Measures

    Attenuated positive, negative and general psychiatric symptoms
    To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.

    Secondary Outcome Measures

    Social and role functioning
    To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.
    Time to all-cause discontinuation.
    To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.
    Adverse effects
    To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.

    Full Information

    First Posted
    November 1, 2012
    Last Updated
    May 23, 2014
    Sponsor
    St. Luke's-Roosevelt Hospital Center
    Collaborators
    The Zucker Hillside Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01724372
    Brief Title
    The Role of Antidepressants or Antipsychotics in Preventing Psychosis
    Official Title
    The Role of Antidepressants or Antipsychotics in Preventing Psychosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    May 2014 (Anticipated)
    Study Completion Date
    May 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    St. Luke's-Roosevelt Hospital Center
    Collaborators
    The Zucker Hillside Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychotic Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antidepressant
    Arm Type
    Experimental
    Arm Description
    Fluoxetine
    Arm Title
    Antipsychotic
    Arm Type
    Active Comparator
    Arm Description
    Aripiprazole
    Intervention Type
    Drug
    Intervention Name(s)
    Antidepressant
    Other Intervention Name(s)
    Fluoxetine
    Intervention Type
    Drug
    Intervention Name(s)
    Antipsychotic
    Other Intervention Name(s)
    Aripiprazole
    Primary Outcome Measure Information:
    Title
    Attenuated positive, negative and general psychiatric symptoms
    Description
    To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Social and role functioning
    Description
    To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.
    Time Frame
    6 months
    Title
    Time to all-cause discontinuation.
    Description
    To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.
    Time Frame
    6 months
    Title
    Adverse effects
    Description
    To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 12-25 years of age (inclusive) Able to understand and speak English Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe Exclusion Criteria: Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features Current psychosis Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features Lifetime diagnosis of substance abuse or dependence (excluding nicotine) Current stimulant treatment Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain Estimated intelligence quotient < 70

    12. IPD Sharing Statement

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    The Role of Antidepressants or Antipsychotics in Preventing Psychosis

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