The Role of Antidepressants or Antipsychotics in Preventing Psychosis

NCT ID: NCT01724372

Last Updated: 2014-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psychotic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Antidepressant

Fluoxetine

Group Type EXPERIMENTAL

Antidepressant

Intervention Type DRUG

Antipsychotic

Aripiprazole

Group Type ACTIVE_COMPARATOR

Antipsychotic

Intervention Type DRUG

Interventions

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Antidepressant

Intervention Type DRUG

Antipsychotic

Intervention Type DRUG

Other Intervention Names

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Fluoxetine Aripiprazole

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Zucker Hillside Hospital

OTHER

Sponsor Role collaborator

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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12-094

Identifier Type: -

Identifier Source: org_study_id

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