Seroquel in Bipolar Depression Versus Lithium
Phase 3
Completed
- Conditions
- Bipolar DisorderBipolar DepressionDepression
- Registration Number
- NCT00206141
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 672
Inclusion Criteria
- Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.
Exclusion Criteria
- Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment,
- History of non-response to an adequate treatment
- Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
- Pregnancy or lactation
- Clinically relevant disease or clinical finding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
- Secondary Outcome Measures
Name Time Method MADRS total score remission MADRS total score response
Trial Locations
- Locations (1)
Research Site
🇺🇦Vinnitsa, Ukraine