Effect on Cognitive Function of a Treatment With Aripiprazole

Otsuka

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329810

CN138-166

Details and patient eligibility

About

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

Enrollment: 500 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

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Experimental group

Treatment:

Drug: Aripiprazole