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Aripiprazole Treatment of Prodromal Patients

Primary Purpose

Schizophrenia, Psychosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring prodrome, ultra high risk, aripiprazole

Eligibility Criteria

13 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 13 to 40 meet criteria for the prodrome for schizophrenia Exclusion Criteria: history of psychosis

Sites / Locations

Institute of Living
Yale School of Medicine

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00237874

First Posted

October 7, 2005

Last Updated

June 5, 2014

Sponsor

Yale University

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00237874

Brief Title

Aripiprazole Treatment of Prodromal Patients

Official Title

Aripiprazole Treatment of Prodromal Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Psychosis

Keywords

prodrome, ultra high risk, aripiprazole

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Primary Outcome Measure Information:

Title

Total Score of the Scale Of Prodromal Symptoms

Description

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).

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 13 to 40 meet criteria for the prodrome for schizophrenia Exclusion Criteria: history of psychosis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott W Woods, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Living

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Facility Name

Yale School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06512

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Aripiprazole Treatment of Prodromal Patients

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