Fluoxetine vs Aripiprazole Comparative Trial (FACT)

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: Aripiprazole; Fluoxetine

Criteria

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.