Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Quetiapine fumarate; Drug: conventional treatment for schizophrenia

• Registration Number: NCT00255515
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-11-17
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-21
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Signed informed consent
• Documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years.
• Clinically stable and in an outpatient setting before entering the study (visit 1).

Exclusion Criteria

• Use of clozapine and quetiapine within two months prior to visit 1.
• If total points are ≤ 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Quetiapine fumarate	quetiapine fumarate
2	conventional treatment for schizophrenia	Conventional treatment for schizophrenia
3	Quetiapine fumarate	quetiapine fumarate + Cognitive Remediation Therapy

Primary Outcome Measures

Name	Time	Method
Social outcome measured by Strauss-Carpenter scale	change from baseline to last visit and end of CRT

Secondary Outcome Measures

Name	Time	Method
Change in PANSS total score	change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
Change in PANSS positive, negative and general psychopathology symptom subscales	change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
Change in cognition as measured by a Cognitive Battery of Tests	change from baseline to end of CRT and from baseline to last visit

Trial Locations

Locations (1)

Research Site; 🇸🇪 Vasteras, Sweden