The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Sponsor

St. Luke's-Roosevelt Hospital Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01724372

Collaborator

The Zucker Hillside Hospital (Other)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorder	Drug: Antidepressant Drug: Antipsychotic	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antidepressant Fluoxetine	Drug: Antidepressant Other Names: Fluoxetine
Active Comparator: Antipsychotic Aripiprazole	Drug: Antipsychotic Other Names: Aripiprazole

Arm

Intervention/Treatment

Experimental: Antidepressant

Fluoxetine

Drug: Antidepressant

Other Names:

Fluoxetine

Active Comparator: Antipsychotic

Aripiprazole

Drug: Antipsychotic

Other Names:

Aripiprazole

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 25 Years

Sexes Eligible for Study:

All

Accepts 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