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 |
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.
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
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.
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