The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Not Applicable

Withdrawn

• Conditions: Psychotic Disorder
• Interventions: Drug: Antidepressant; Drug: Antipsychotic

• Registration Number: NCT01724372
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Status Verified: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-23
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antidepressant	Antidepressant	Fluoxetine
Antipsychotic	Antipsychotic	Aripiprazole

Primary Outcome Measures

Name	Time	Method
Attenuated positive, negative and general psychiatric symptoms	6 months	To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.

Secondary Outcome Measures

Name	Time	Method
Social and role functioning	6 months	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.	6 months	To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.
Adverse effects	6 months	To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.