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A Study of Aripiprazole in Patients With Schizophrenia in General Psychiatric Practices

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00292409
First received: September 12, 2005
Last updated: November 7, 2013
Last verified: May 2008
  Purpose

The purpose of this clinical research study is to evaluate the overall effectiveness of 8 week of aripiprazole treatment.


Condition Intervention Phase
Schizophrenia and Schizoaffective Disorder
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Prospective Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Clinical Global Impression-Improvement at endpoint

Secondary Outcome Measures:
  • Clinical Global Impression scale
  • Investigator's Assessment Questionnaire
  • Patient preference of medication at endpoint

Estimated Enrollment: 400
Study Start Date: March 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of schizophrenia or schizoaffective disorder being treated as outpatients,no response to past antipsychotic treatment and patients who symptoms are notoptimally controlled defined as CGI- S<7

Exclusion Criteria:

  • pregnant or breastfeeding,patients at risk for committing suicide,diagnosis of mood disorders, delirium, dementia and other cognitive disorders,patients treatment resistant to otherantipyschotic medications and treatment with a long acting psychotic in which the last dose was within 3 months of treatment phase
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292409

Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00292409     History of Changes
Other Study ID Numbers: CN138-125
Study First Received: September 12, 2005
Last Updated: November 7, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014