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
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
1 other identifier
interventional
120
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 5, 2009
February 1, 2009
1.8 years
February 4, 2009
February 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy variable for this study is the YMRS total score change from baseline to Day 28 (LOCF).
28 days
Secondary Outcomes (3)
To evaluate the effectiveness of quetiapine fumarate
28 days
To evaluate the relationship between the serum brain-derived neurotrophic factor and quetiapine fumarate
28 days
To evaluate the safety and tolerability of quetiapine fumarate
28 days
Study Arms (1)
Quetiapine Fumarate arm
EXPERIMENTALQuetiapine Fumarate arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- Written informed consent was submitted by subjects or their legal guardian
- Bipolar disorder (296.0x, 296.4x) is diagnosed by the Structured Clinical Interview for DSM-IV Axis I Disorders - Patient Edition (SCID), based on the 4th edition of US Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- Aged between 18 and 65, male and female, Han nationality
- In the acute phase of mania episode and YMRS total score is at least 22 at baseline.
- The following drugs (lithium carbonate, sodium valproate, risperidone or olanzapine) were received as previous maintain treatment( monotherapy or combination therapy) in adequate dose according to label within three months before this mania episode.
- Child-bearing potential female patients should conduct urine pregnancy test (HCG) at the enrolment, and the result should be negative; and also willing to take contraception measures during the study period
- Be able to understand and comply with the requirements of the study
You may not qualify if:
- Women in pregnancy or lactation
- The duration of this mania episode is at most 2 weeks at enrollment.
- DSM-IV Axis I Disorders except bipolar disorder (296.0x, 296.4x)
- Patients with symptoms of obvious suicide (MADRS No. 10 score ≥4), self-injured or harmful to others, as judged by the investigators
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigators
- Patients with non-compliance by his history as judged by the investigators
- Use of any potent cytochrome P450 3A4 inhibitors in the 14 days preceding randomization, including but not limited as ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, and saquinavir
- Use of potent cytochrome P450 inducers in the 14 days preceding randomization, including but not limited as phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- long-acting antipsychotic drug was injected within 1 injection interval (prolonged acting injection) before randomization
- Use of clozapine in the 28 days preceding randomization
- Substance or alcohol dependence according to the DSM-IV criteria at randomization (except complete recovered, and caffeine and nicotine dependence)
- Dependence for the following drugs according to the DSM-IV standard at 4 weeks preceding randomization: opioids, amphetamine, barbiturates, cocaine, cannabis, or hallucinogens
- Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment.
- Clinical evidence for the relevant diseases (e.g. renal or hepatic dysfunction, severe coronary heart disease, cerebrovascular disease, hepatitis and acquired immunodeficiency syndrome (AIDS))
- Unstable conditions (e.g. hypertension, congestive heart failure, unstable angina pectoris) or in the opinion of the investigator would be negatively affected by study medication or that would affect study medication, or has a medical history of chronic body disease.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Mental Hospital
Guangzhou, China/Guangdong Province, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Li, Professor
Guangzhou Mental Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 5, 2009
Study Start
December 1, 2008
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
February 5, 2009
Record last verified: 2009-02