Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00254774
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-17
• Study Completion: 2006-03
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-14
• Last Update Posted: 2007-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Signed informed consent, men and women aged ³18 to £65 years with diagnosis of DSM-IV criteria for bipolar I or II disorder, most recent episode manic, hypomanic, mixed or depressive with Rapid Cycling.

Exclusion Criteria

• Substance or alcohol dependence, female patients who are pregnant, lactating or at risk of pregnancy, diagnosis of schizophrenia or borderline personality disorder or antisocial personality disorder, history of seizure disorder, acute suicidal or external aggressive behaviour, legal incapacity or indication for treatment against the will of the patient by law.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of clinically relevant recurrences of depression or mania. Recurrence is defined by a change in LCM-C/P to moderate or severe or by 2 or more steps. End of an episode is defined as reduction to mild or baseline or by 2 or more steps.

Secondary Outcome Measures

Name	Time	Method
Absolute change from baseline on the (recalculated) HAM-D, YMRS, MADRS, total score. Absolute change from baseline on the CGI-BP severity score per dimension (mania, depression, overall bipolar illness).

Trial Locations

Locations (1)

Research Site; 🇩🇪 München, Germany