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Aripiprazole Treatment of Prodromal Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237874
First Posted: October 12, 2005
Last Update Posted: June 6, 2014
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.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Yale University
  Purpose
We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole.

Condition Intervention Phase
Schizophrenia Psychosis Drug: Aripiprazole Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole Treatment of Prodromal Patients

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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).


Enrollment: 15
Study Start Date: February 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • history of psychosis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00237874


Locations
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
Investigators
Principal Investigator: Scott W Woods, MD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00237874     History of Changes
Other Study ID Numbers: YaleHIC26037
First Submitted: October 7, 2005
First Posted: October 12, 2005
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by Yale University:
prodrome
ultra high risk
aripiprazole

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