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.
|Condition or Disease||Intervention/Treatment||Phase|
To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects
Arms and Interventions
|Active Comparator: Aripiprazole
To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (2mg wk1, 5mg wk2, 10mg wk3, 5-30 mg wk4-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need (5-30mg).
see arm description
|Active Comparator: Fluoxetine
To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (5mg wk1, 10mg wk2, 20mg wk3, 10-60mg wk3-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need(10-60mg).
see arm description
Primary Outcome Measures
- Time to treatment failure [24 weeks]
Time to either all-cause-discontinuation or need to add another psychotropic agent
Secondary Outcome Measures
- Change in Prodromal Symptoms (SOPS) total scores [24 weeks]
- Number of patients with specific adverse effects [24 weeks]
- Change in social and role functioning scores [24 weeks]
- Subjective well-being questionnaire [24 weeks]
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.
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.
Contacts and Locations
|1||The Zucker Hillside Hospital||Glen Oaks||New York||United States||11004|
Sponsors and Collaborators
- Northwell Health
- Principal Investigator: Christoph U Correll, MD, North Shore LIJ
Study Documents (Full-Text)None provided.