A Study to Evaluate the Efficacy and Safety of Flexible Dose of Quetiapine Fumarate (Seroquel) Switching From Other Drugs in the Treatment of Acute Manic Patients With Bipolar Disorder
Recruitment status was Recruiting
Bipolar disorder (BD) is also named as a bipolar affective disorder, belonging to a kind of severe mental disorder involving both mania or hypomania and depression episode, with lifetime prevalence between 1.2 - 1.6%. The hygienic burden of bipolar disorder is high, and its disease burden lies in top 10 position among the population of 15 - 44 years of old patients and concomitant with relative high suicide rate (10 - 15%) and mutilation rate, as reported by the World Health Organization (WHO) 2001 Annual Report. Drug treatment is one of the main treatment methods for this kind of disease, and the dose selected will interfere the efficacy and prognosis of the patient.
Quetiapine fumarate (Seroquel) is a dibenzothiazepine derivative, which is widely used in the world. It has the indications in schizophrenia, bipolar mania and depression approved by FDA. Quetiapine fumarate has been used in China for almost 10 years, which is in the treatment of schizophrenia. The indication of bipolar mania has been approved by SFDA recently. Exploration of the relationship between the dose and efficacy has been a hot spot in the clinical practice as the drug has a broad action spectrum and wide dose range (200mg/d－800mg/d).
Brain-derived neurotrophic factor (BDNF) plays an important role in the pathophysiology of bipolar disorder. Some clinical studies indicate the blood BDNF level decreased during the depression phase in the bipolar disorder, and the blood BDNF level is negative proportional to the severity of the depression; and the same phenomenon was found, i.e. the blood BDNF level decreased during the manic phase in the bipolar disorder, and the blood BDNF level is negative proportional to the severity of the mania. Quetiapine fumarate was found to reduce the decreasing of the expression of BDNF in the rat hippocampus and brain mantle in some animal experiments, indicating quetiapine fumarate has the possibility on potential interfering BDNF in the treatment. However, few study on comparison of the blood BDNF level between pre and post treatment in the bipolar disorder was conducted.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Multicenter, Single Arm, 4-Week Study to Evaluate the Efficacy and Safety of Flexible Dose of Quetiapine Fumarate (Seroquel) Switching From Other Drugs in the Treatment of Acute Manic Patients With Bipolar Disorder|
- The primary efficacy variable for this study is the YMRS total score change from baseline to Day 28 (LOCF). [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- To evaluate the effectiveness of quetiapine fumarate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- To evaluate the relationship between the serum brain-derived neurotrophic factor and quetiapine fumarate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- To evaluate the safety and tolerability of quetiapine fumarate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Quetiapine Fumarate arm
Quetiapine Fumarate arm
Drug: quetiapine fumarate tablet (Seroquel)
Investigational product: quetiapine fumarate tablet (Seroquel) , 25 mg, 200 mg, 300mg, manufactured by AstraZeneca.The total daily doses of quetiapine fumarate will be increased to 600mg/d on the 6th since enrolment day. At day 7 or later, the dose can be adjusted in the range of 400- 800mg/day.
This is a multicenter, open label, 4-week study. Study subjects are defined in Chinese Han nationality patients with acute mania of bipolar disorder (inpatients or outpatients). The screening phase is up to 7 days. The eligible patients in the screening phase can be enrolled into the treatment phase, the target dose is 400-800mg/day, and treatment period will last for 4 weeks. The objective is to evaluate the efficacy of quetiapine fumarate switching from other drugs used as monotherapy in the treatment of acute mania with bipolar disorder, and the relationship between the serum BDNF and quetiapine fumarate.
|Contact: Jie Li, Professorfirstname.lastname@example.org|
|Contact: Dong Xiao Chen, Master||020-81801909|
|China, China/Guangdong province|
|Guangzhou Mental Hospital||Recruiting|
|Guangzhou, China/Guangdong province, China|
|Contact: Jie Li, Professor 020-81801909 email@example.com|
|Principal Investigator:||Jie Li, Professor||Guangzhou Mental Hospital|