Affective Psychosis, Bipolar, Mania, Manic-Depressive Psychosis, Manic Disorder, Manic State, Psychoses, Manic-Depressive
Conditions
Keywords
Bipolar Disorder, Bipolar Mania, 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 Mania for 3 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 Disorder, with most recent episode being manic or mixed * Inpatient hospital admission for the first 4 days of study treatment
Exclusion criteria
* \>8 mood episodes within the last 12 months * Use of prohibited medication * 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 to final visit in the YMRS total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS. | — |
Countries
United States
Outcome results
None listed