Affective Psychosis, Bipolar, Depression, Bipolar, Manic-Depressive Psychosis, Psychoses, Manic-Depressive
Conditions
Keywords
Bipolar Disorder, Bipolar Depression,, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate
Brief summary
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks. 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
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent * Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder * Outpatient status at enrollment
Exclusion criteria
* Patients with \>8 mood episodes during the past 12 years * Use of prohibited medications * Substance or alcohol abuse or dependence * Current suicide risk or suicide attempt within last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in depression symptoms by final visit as measured by the MADRS total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C | — |
Countries
United States
Outcome results
None listed