The Role of Antidepressants or Antipsychotics in Preventing Psychosis
This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis.
Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Role of Antidepressants or Antipsychotics in Preventing Psychosis|
- Attenuated positive, negative and general psychiatric symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.
- Social and role functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.
- Time to all-cause discontinuation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.
- Adverse effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Other Name: Fluoxetine
Active Comparator: Antipsychotic
Other Name: Aripiprazole
|Contact: Michael L Birnbaum, MDCMfirstname.lastname@example.org|
|United States, New York|
|St. Luke's Hospital||Recruiting|
|New York, New York, United States, 10025|
|Contact: Nahima Ahmed, MPH 212-523-5237 email@example.com|
|Principal Investigator: Michael L Birnbaum, MDCM|