The Role of Antidepressants or Antipsychotics in Preventing Psychosis

• Status: Withdrawn
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborator: The Zucker Hillside Hospital
• Treatments: Antidepressive Agents; Antipsychotic Agents; Aripiprazole; Fluoxetine

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