The Role of Antidepressants or Antipsychotics in Preventing Psychosis

NCT01724372 | Withdrawn

• 1 other identifier: 12-094
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychotic Disorder

Outcome Measures

Primary Outcomes (1)

• Attenuated positive, negative and general psychiatric symptoms

  To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.

  6 months

Secondary Outcomes (3)

• Social and role functioning

  6 months

• Time to all-cause discontinuation.

  6 months

• Adverse effects

  6 months

Study Arms (2)

Antidepressant

EXPERIMENTAL

Fluoxetine

Drug: Antidepressant

Antipsychotic

ACTIVE COMPARATOR

Aripiprazole

Drug: Antipsychotic

Interventions

Antidepressant DRUG

Also known as: Fluoxetine

Antidepressant

Antipsychotic DRUG

Also known as: Aripiprazole

Antipsychotic

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• The Zucker Hillside Hospital: collaborator

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Antidepressive Agents; Fluoxetine; Antipsychotic Agents; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Propylamines; Amines; Organic Chemicals; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 9, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 26, 2014

Record last verified: 2012-11