Aripiprazole Treatment of Prodromal Patients

Phase 2

Completed

• Conditions: Schizophrenia; Psychosis

• Registration Number: NCT00237874
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• history of psychosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total Score of the Scale Of Prodromal Symptoms	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).

Trial Locations

Locations (2)

Institute of Living; 🇺🇸 Hartford, Connecticut, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States