Study identifier:D1443L00023
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
An Open Label, 4-Week, Randomised, Multi-Centre, Phase IV Study to Compare the Efficacy and Safety of Quetiapine Fumarate (Seroquel) as Mono-Therapy or adjunct to lithium in the Treatment of Patients with Acute Mania in Bipolar Disorder
Acute Mania in Bipolar Disorder
Phase 4
No
Quetiapine Fumarate, Lithium
All
376
Interventional
18 Years - 60 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
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
Location
Location
Baoding, Hebei, China
Location
Beijing, Beijing, China
Location
Chengdu, Sichuan, China
Location
Daqing, Heilongjiang, China
Location
Guangzhou, Guangdong, China
Location
Hangzhou, Zhejiang, China
Location
Huzhou, Zhejiang, China
Location
Kuming, Yunnan, China
Arms | Assigned Interventions |
---|---|
Experimental: 1 Quetiapine Fumarate - tablets | Drug: Quetiapine Fumarate Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator. Tablets Other Name: Seroquel |
Experimental: 2 Quetiapine Fumarate - tablets and Lithium | Drug: Quetiapine Fumarate Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator. Tablets Other Name: Seroquel Drug: Lithium Oral treatment, twice daily. 250 mg/day to 2000mg/day from Day1 to Day 7, 500mg/day to 2000mg/day thereafter, judged by the investigator. |
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