The Role of Antidepressants or Antipsychotics in Preventing Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724372
Recruitment Status : Withdrawn
First Posted : November 9, 2012
Last Update Posted : May 26, 2014
The Zucker Hillside Hospital
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorder Drug: Antidepressant Drug: Antipsychotic Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Antidepressants or Antipsychotics in Preventing Psychosis
Study Start Date : October 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Antidepressant
Drug: Antidepressant
Other Name: Fluoxetine

Active Comparator: Antipsychotic
Drug: Antipsychotic
Other Name: Aripiprazole

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Social and role functioning [ Time Frame: 6 months ]
    To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.

  2. Time to all-cause discontinuation. [ Time Frame: 6 months ]
    To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.

  3. Adverse effects [ Time Frame: 6 months ]
    To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Responsible Party: St. Luke's-Roosevelt Hospital Center Identifier: NCT01724372     History of Changes
Other Study ID Numbers: 12-094
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: November 2012

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antidepressive Agents
Antipsychotic Agents
Psychotropic Drugs
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors