Conditions: Bipolar Depression
Keywords: major depressive episodes FK949E quetiapine bipolar depression bipolar disorder
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 22
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.

Detailed description:

Arms:
arm 1: Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks). arm 2: Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).

Interventions: intervention 1: FK949E
Intervention descriptions: intervention 1: A tablet containing 50 mg or 150 mg of quetiapine taken orally.

Protocol document: