Aripiprazole Treatment of Prodromal Patients

June 5, 2014 updated by: Yale University
We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • history of psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Score of the Scale Of Prodromal Symptoms
Time Frame: 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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Scott W Woods, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YaleHIC26037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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