A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients

Effect on Cognitive Function of a Treatment With Aripiprazole

Sponsors

Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborator: Otsuka America Pharmaceutical

Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Brief Summary

To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.

Overall Status Completed
Start Date March 2005
Completion Date March 2006
Primary Completion Date March 2006
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical Global Impression scale at endpoint
Secondary Outcome
Measure Time Frame
Change in Clinical Global Impression scale and cognition scales at endpoint
Enrollment 500
Condition
Intervention

Intervention type: Drug

Intervention name: Aripiprazole

Description: Tablets, oral, 15 mg, once daily, 12 weeks.

Arm group label: Switch

Other name: Abilify

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosis of Schizophrenia

- score of 2-6 in the CGI-S scale at basline

- ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment

Exclusion Criteria:

- women of child bearing potential

- women pregnant or breast feeding

- patients with a score of 0,-1 or 7

- substance use

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Principal Investigator Bristol-Myers Squibb
Verification Date

February 2012

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Switch

Arm group type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov