The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Study Overview
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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.

Official Title
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The Role of Antidepressants or Antipsychotics in Preventing Psychosis

Conditions
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Psychotic Disorder

Intervention / Treatment
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* Drug: Antidepressant
* Drug: Antipsychotic


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antidepressant<br>Fluoxetine | Drug: Antidepressant<br> <br> * Other names: Fluoxetine;|
| Active Comparator: Antipsychotic<br>Aripiprazole | Drug: Antipsychotic<br> <br> * Other names: Aripiprazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attenuated positive, negative and general psychiatric symptoms | To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| Time to all-cause discontinuation. | To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication. | 6 months | 
| Adverse effects | To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects. | 6 months |