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NCT00237874 Clinical Trial

Aripiprazole Treatment of Prodromal Patients

Schizophrenia Clinical Trial

Official title:
Aripiprazole Treatment of Prodromal Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00237874
Other study ID # YaleHIC26037
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received October 7, 2005
Last updated June 5, 2014
Start date February 2004
Est. completion date February 2007

Study information
Verified date June 2014
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 40 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- history of psychosis

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aripiprazole

Locations
Country Name City State
United States Institute of Living Hartford Connecticut
United States Yale School of Medicine New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total Score of the Scale Of Prodromal Symptoms 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). 8 weeks No
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