Bipolar Disorder Clinical Trial
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
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.
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. ;
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