Phase III/Seroquel SR Bipolar Depression Monotherapy - US
Sponsored by AstraZeneca
About this trial
Last updated 16 years ago
Study ID
D144CC00002
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 65 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 18 years ago
What is this trial about?
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.
What are the participation requirements?
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.