Bipolar Depression, Bipolar Disorder, Depression
Conditions
Keywords
Bipolar disorder, bipolar depression, depression
Brief summary
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
Interventions
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
* Male and female out-patients aged 18 to 65 years inclusive * Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
Exclusion criteria
* Current period of depression lasting less than 4 weeks or more than 12 months * Use of prohibited medication * Substance or alcohol dependence or abuse * Current suicide risk or suicide attempt within 6 months * Breast feeding or pregnancy * Clinically relevant disease or clinical finding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary variables supportive to the primary objective: | — |
| MADRS total score response | — |
| MADRS total score remission | — |
Countries
Australia, Chile, Colombia, Costa Rica, Greece, Mexico, Peru, Romania, South Africa, Turkey (Türkiye), United States
Outcome results
None listed