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

11-199

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.

2014-07-01

2022-04-04

2022-04-04

Terminated

Early phase I

9

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

2023-11-15