Fluoxetine vs Aripiprazole Comparative Trial (FACT)



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:12 - 25
Updated:2/22/2019
Start Date:July 2014
End Date:December 2019
Contact:Christoph U Correll, MD
Email:ccorrell@nshs.edu
Phone:718-470-4812

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

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

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.
We found this trial at
1
site
Glen Oaks, New York 11004
Phone: 718-470-4812
?
mi
from
Glen Oaks, NY
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