Fluoxetine vs Aripiprazole Comparative Trial (FACT)

  • End date
    Jun 30, 2023
  • participants needed
  • sponsor
    Northwell Health
Updated on 24 February 2021


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.


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

Condition Attenuated Psychosis Syndrome
Treatment Aripiprazole, Fluoxetine
Clinical Study IdentifierNCT02357849
SponsorNorthwell Health
Last Modified on24 February 2021


Yes No Not Sure

Inclusion Criteria

Is your age between 12 yrs and 25 yrs?
Gender: Male or Female
Do you have Attenuated Psychosis Syndrome?
Do you have any of these conditions: Do you have Attenuated Psychosis Syndrome??
Do you have any of these conditions: Do you have Attenuated Psychosis Syndrome??
Do you have any of these conditions: Do you have Attenuated Psychosis Syndrome??
consent obtained from patients and their parents (assent for patients under 18)
age 12-25 years (inclusive)
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\
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