This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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This study has been withdrawn prior to enrollment.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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]
    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 ]
    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 ]
    To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.

  • Adverse effects [ Time Frame: 6 months ]
    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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 processed this record on September 21, 2017