To Evaluate the Efficiency and Safety of Quetiapine Fumarate in the Treatment of Acute Manic Patients With Bipolar Disorder.
Recruitment status was: Recruiting
This is an open label, randomised, parallel-group study to compare the efficacy and safety of quetiapine and valproate used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or valproate group on Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28. Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol.
At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring. Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Randomised, Valproate-Controlled Study to Evaluate the Efficiency and Safety of Quetiapine Fumarate in the Treatment of Acute Manic Patients With Bipolar Disorder.|
- The outcome measure is the change from baseline in YMRS total score at Day 28 (LOCF). [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
- These changes from baseline in PANSS,MADRS, CGI total score at Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||August 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: The arm 1
Quetiapine fumarate tablet:25mg and 200mg
Drug: Quetiapine fumarate
Investigational product: quetiapine fumarate tablet 25 mg and 200 mg
Active Comparator: The arm 2
Sodium valproate tablet 200mg
Drug: Sodium valproate
Sodium valproate tablet 200 mg
The rationale for using the quetiapine to treat patients with acute mania is multifold. A potential major advantage for quetiapine is its demonstrated tolerability. Because of the low incidence of EPS, quetiapine should be better tolerated than other antipsychotic medications in this sensitive patient population. The limited potential for weight gain and prolactin elevation may promote long-term treatment compliance.
The effect of quetiapine alone or adjunctive with mood stabilizers in the treatment of acute mania in patients with bipolar disorder has been confirmed through 4 phase III clinical trials (8,9). Based on the results of these clinical trials, the use of Seroquel in the acute mania of bipolar disorder has been approved in US, UK and other major markets in Europe. Quetiapine is also been recommended as alternative therapy for acute mania treatment in the practice guideline (10). The present study is to assess the effectiveness of quetiapine and valproate in the treatment of Chinese patients with acute mania over a treatment period of 4 weeks. Primary objective The primary objective of the study is to evaluate the effectiveness of quetiapine fumarate used as monotherapy in the treatment of symptoms of acute mania in patients with bipolar disorder, by evaluation of the change from baseline in YMRS total score at Day 28 (LOCF).
The secondary objectives of the study are to evaluate the following:
- The effectiveness of quetiapine used as monotherapy to treat symptoms in patients with acute mania by evaluation of YMRS/CGI response rate at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to improve clinical status in patients with acute mania by evaluation of change from baseline in CGI-S score at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to treat depressive symptoms in patients with acute mania by evaluation of change from baseline in MADRS total score at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to treat psychotic symptoms in patients with acute mania by evaluation of change from baseline in PANSS total score at Day 28 (LOCF)
- The safety and tolerability of quetiapine used as monotherapy to treat symptoms in patients with acute mania
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742638
|Shanghai Mental Health Center|
|Shanghai, Shanghai, China, 200030|