Bipolar I Disorder
Conditions
Keywords
Bipolar I Disorder, Manic Depressive Disorder, Manic Depression
Brief summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) * At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode. * Able to understand and comply with the requirements of the study.
Exclusion criteria
* Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year. * Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator. * Previously randomized into this study or D1447C00126
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event | — |
Countries
Australia, Belgium, Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Norway, Poland, Russia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed