The Role of Antidepressants or Antipsychotics in Preventing Psychosis

This study has been withdrawn prior to enrollment.
The Zucker Hillside Hospital
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center Identifier:
First received: November 1, 2012
Last updated: May 23, 2014
Last verified: November 2012

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 Intervention
Psychotic Disorder
Drug: Antidepressant
Drug: Antipsychotic

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: October 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antidepressant
Drug: Antidepressant
Other Name: Fluoxetine
Active Comparator: Antipsychotic
Drug: Antipsychotic
Other Name: Aripiprazole


Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: St. Luke's-Roosevelt Hospital Center Identifier: NCT01724372     History of Changes
Other Study ID Numbers: 12-094 
Study First Received: November 1, 2012
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antidepressive Agents
Antipsychotic Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents processed this record on May 24, 2016