Aripiprazole Treatment of Prodromal Patients

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: NCT00237874
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 6, 2014
Bristol-Myers Squibb
Information provided by (Responsible Party):
Yale University

Brief Summary:
We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychosis Drug: Aripiprazole Phase 2 Phase 3

Detailed Description:
This is an 8 week trial with extension for responders out to one year. All patients receive active medication; there is no placebo. Patients must meet criteria for the schizophrenia prodrome according to the Structured Interview for Prodromal Syndromes. Patients receive counseling as well. All counseling and medication are free of charge.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole Treatment of Prodromal Patients
Study Start Date : February 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. Total Score of the Scale Of Prodromal Symptoms [ Time Frame: 8 weeks ]
    This is a 19-item scale with items scores 0-6. Treatment response is defined as all 5 Scale of Prodromal Syndromes positive symtpom items being rate below the prodromal range (< or equal to 2).

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 13 to 40 meet criteria for the prodrome for schizophrenia

Exclusion Criteria:

  • history of psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237874

United States, Connecticut
Institute of Living
Hartford, Connecticut, United States, 06106
Yale School of Medicine
New Haven, Connecticut, United States, 06512
Sponsors and Collaborators
Yale University
Bristol-Myers Squibb
Principal Investigator: Scott W Woods, MD Yale University

Responsible Party: Yale University Identifier: NCT00237874     History of Changes
Other Study ID Numbers: YaleHIC26037
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by Yale University:
ultra high risk

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs