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Clinical Trials/NCT01724372
NCT01724372
Withdrawn
Not Applicable

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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
May 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

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