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Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring agitated schizophrenic patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Agitated schizophrenic patients

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Instituton
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 7, 2002
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00036127
Brief Title
Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

5. Study Description

Brief Summary
Study to learn if the alternate formulation is effective in agitated schizophrenic patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
agitated schizophrenic patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
aripiprazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Agitated schizophrenic patients
Facility Information:
Facility Name
Local Institution
City
Anaheim
State/Province
California
Country
United States
Facility Name
Local Institution
City
Cerritos
State/Province
California
Country
United States
Facility Name
Local Institution
City
Chula Vista
State/Province
California
Country
United States
Facility Name
Local Institution
City
Rosemead
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Local Instituton
City
Hoffman Estates
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Local Institution
City
Nashua
State/Province
New Hampshire
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17284138
Citation
Tran-Johnson TK, Sack DA, Marcus RN, Auby P, McQuade RD, Oren DA. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Jan;68(1):111-9. doi: 10.4088/jcp.v68n0115.
Results Reference
derived

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Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders

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