Bipolar Depression, Bipolar Disorder, Depression
Conditions
Keywords
Bipolar disorder, bipolar depression, depression
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.
Interventions
DRUGQuetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS total score response | — |
| MADRS total score remission | — |
Countries
Canada, Croatia, Estonia, Germany, Indonesia, Latvia, Lithuania, Malaysia, Norway, Philippines, Poland, Russia, Serbia, South Korea, Taiwan, Ukraine
Outcome results
None listed