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

Schizophrenia and Schizoaffective Disorder Clinical Trial

Official title:

A Prospective Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292409
• Other study ID #: CN138-125
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 7, 2013
• Start date: March 2005
• Est. completion date: November 2007

Study information

• Verified date: May 2008
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Schizoaffective Disorder

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression-Improvement at endpoint
Secondary	Clinical Global Impression scale
Secondary	Investigator's Assessment Questionnaire
Secondary	Patient preference of medication at endpoint

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm