Aripiprazole Treatment of Prodromal Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00237874
First received: October 7, 2005
Last updated: June 5, 2014
Last verified: June 2014
  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:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Total Score of the Scale Of Prodromal Symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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

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
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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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00237874     History of Changes
Other Study ID Numbers: YaleHIC26037
Study First Received: October 7, 2005
Last Updated: June 5, 2014
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 July 26, 2014