Back to resultsEfficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
quetiapine fumarate or valproate
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder I or II with Rapid Cycling
Eligibility Criteria
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.
Sites / Locations
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00254774
Brief Title
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
Official Title
Pilot Study of the Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling: an Open Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder I or II with Rapid Cycling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
quetiapine fumarate or valproate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Germany Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Freiburg
Country
Germany
Facility Name
Research Site
City
München
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
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