The Role of Antidepressants or Antipsychotics in Preventing Psychosis
|ClinicalTrials.gov Identifier: NCT01724372|
Recruitment Status : Withdrawn
First Posted : November 9, 2012
Last Update Posted : May 26, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Psychotic Disorder||Drug: Antidepressant Drug: Antipsychotic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Role of Antidepressants or Antipsychotics in Preventing Psychosis|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2014|
Other Name: Fluoxetine
Active Comparator: Antipsychotic
Other Name: Aripiprazole
- Attenuated positive, negative and general psychiatric symptoms [ Time Frame: 6 months ]To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.
- Social and role functioning [ Time Frame: 6 months ]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 ]To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.
- Adverse effects [ Time Frame: 6 months ]To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.