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The Role of Antidepressants or Antipsychotics in Preventing Psychosis

This study is currently recruiting participants.
Verified November 2012 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Collaborator:
The Zucker Hillside Hospital
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01724372
First received: November 1, 2012
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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.


Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antidepressant
Fluoxetine
 Drug: Antidepressant
Other Name: Fluoxetine
Active Comparator: Antipsychotic
Aripiprazole
 Drug: Antipsychotic
Other Name: Aripiprazole

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724372

Contacts
Contact: Michael L Birnbaum, MDCM 212-523-2932 mbirnbau@chpnet.org

Locations
United States, New York
St. Luke's Hospital Recruiting
New York, New York, United States, 10025
Contact: Nahima Ahmed, MPH     212-523-5237     nahmed@chpnet.org    
Principal Investigator: Michael L Birnbaum, MDCM            
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
The Zucker Hillside Hospital
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01724372     History of Changes
Other Study ID Numbers: 12-094
Study First Received: November 1, 2012
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Second-Generation
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Fluoxetine
Aripiprazole
Antipsychotic Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 19, 2013