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Aripiprazole Treatment of Prodromal Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00237874
First received: October 7, 2005
Last updated: October 14, 2008
Last verified: October 2008
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole Treatment of Prodromal Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Scale Of Prodromal Symptoms

Estimated Enrollment: 15
Study Start Date: February 2004
Estimated Study Completion Date: February 2007
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

Ages Eligible for Study:   13 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00237874     History of Changes
Other Study ID Numbers: YaleHIC26037
Study First Received: October 7, 2005
Last Updated: October 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
prodrome
ultra high risk
aripiprazole

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013