drugset / Trial / NCT00672490
Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder
RandomizedParallel-groupOpen-labelTreatment
Summary
To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation
Timeline
- Start
- 2008-04
- Primary completion
- 2009-07
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lithium | Unknown | 500 mg | Oral |
| Subject | Lithium | Unknown | 2000 mg | Oral |
| Subject | Quetiapine | Small molecule | 600 mg | Oral |
| Subject | Quetiapine | Small molecule | 800 mg | Oral |