Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Study Overview
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Brief Summary
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We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.

Detailed Description
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To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects

Official Title
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The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)

Conditions
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Attenuated Psychosis Syndrome

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Fluoxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: consent obtained from patients and their parents (assent for patients under 18); age 12-25 years (inclusive); English-speaking; at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe. Exclusion Criteria: lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features; current psychosis (any positive symptom SOPS score of 6, i.e., extreme); current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features; current stimulant treatment; history of neurological, neuroendocrine or other medical condition known to affect the brain; any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine; past or current substance dependence; sunstance abuse within the last 4 weeks; IQ < 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aripiprazole<br>To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (2mg wk1, 5mg wk2, 10mg wk3, 5-30 mg wk4-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need (5-30mg). | Drug: Aripiprazole<br>* see arm description<br>* Other names: Abilify;|
| Active Comparator: Fluoxetine<br>To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (5mg wk1, 10mg wk2, 20mg wk3, 10-60mg wk3-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need(10-60mg). | Drug: Fluoxetine<br>* see arm description<br>* Other names: Prozac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Treatment Failure | Time to either all-cause-discontinuation or need to add another psychotropic agent | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prodromal Symptoms (SOPS) Total Scores | Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse) | 24 weeks | 
| Number of Patients With Specific Adverse Effects | Number of patients with any adverse effects based on spontaneous report | 24 weeks | 
| Change in Social and Role Functioning Scores | Change in social and role functioning scores (range: 0-10, higher sores = better outcome) | 24 weeks | 
| Subjective Well-being Questionnaire | Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being) | 24 weeks |