Aripiprazole Treatment of Prodromal Patients - Full Text View

Sponsors and Collaborators:	Yale University Bristol-Myers Squibb
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00237874

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 II Phase III

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Aripiprazole Treatment of Prodromal Patients

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
Yale School of Medicine
New Haven, Connecticut, United States, 06512
Institute of Living
Hartford, Connecticut, United States, 06106

Sponsors and Collaborators

Yale University

Bristol-Myers Squibb

Investigators

Principal Investigator:

Scott W Woods, MD

Yale University

More Information

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

Keywords provided by Yale University:

prodrome
ultra high risk
aripiprazole

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009