Ignite Creation Date:
2024-05-05 @ 9:12 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00837343
Status:
UNKNOWN
Last Update Posted:
2009-02-05
First Post:
2009-02-04
Brief Title:
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
Sponsor:
Guangzhou Mental Hospital
Organization:
Guangzhou Mental Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 12 - 16 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 200mgd-800mgd
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 ie 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
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 200mgd-800mgd
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 ie 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
Detailed Description:
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 400-800mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None