The Role of Antidepressants or Antipsychotics in Preventing Psychosis
Overview
- Phase
- Not Applicable
- Intervention
- Antidepressant
- Conditions
- Psychotic Disorder
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Primary Endpoint
- Attenuated positive, negative and general psychiatric symptoms
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •12-25 years of age (inclusive)
- •Able to understand and speak English
- •Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe
Exclusion Criteria
- •Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features
- •Current psychosis
- •Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features
- •Lifetime diagnosis of substance abuse or dependence (excluding nicotine)
- •Current stimulant treatment
- •Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain
- •Estimated intelligence quotient \< 70
Arms & Interventions
Antidepressant
Fluoxetine
Intervention: Antidepressant
Antipsychotic
Aripiprazole
Intervention: Antipsychotic
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Social and role functioning(6 months)
- Time to all-cause discontinuation.(6 months)
- Adverse effects(6 months)