Conditions: Bipolar Disorder
Keywords: bipolar disorder, mania, depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: no

Brief summary:
To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.

Detailed description:

Arms:
arm 1: quetiapine SR, 200-600mg, po, qd arm 2: quetiapine SR placebo, 200-600mg, po qd

Interventions: intervention 1: quetiapine SR intervention 2: quetiapine sr placebo
Intervention descriptions: intervention 1: quetiapine SR, dose range 200-600mg, each night QHS for 6mos intervention 2: quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos

Protocol document: