NCT00477373已完成4 期
Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP.
研究概览
简要总结
To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode according to DSM IV (APA 1994) over a 12 weeks period of treatment.
To evaluate the clinical safety of Di-valproate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In or out patients
- •Patients with a current diagnosis of Bipolar I Disorder according to DSM IV (296)
- •Patients suffering from a current manic episode or mixed episode
排除标准
- •Patients who participated in a clinical trial within the three preceding months
- •Patients with a history of valproate intolerance defined as valproate discontinuation due to medically significant adverse effects.
- •Patients with a CNS neoplasm, demyelinating disease, degenerative neurological disorder, active CNS infection or any progressive disorder
- •Patients with a history of seizure disorder, cerebral vascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, known EEG with frank paroxysmal activity or a known CT scan of the brain demonstrating gross structural abnormalities
- •Patients with uncontrolled gastro-intestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease
- •Patients with acute or chronic hepatitis
- •Patients with current or past pancreatitis
- •Patients with recent history (3 months or less) of substance or alcohol dependence according to DSM IV
- •Pregnancy or lactation. Women of child bearing age should be using a reliable contraceptive method
- •Patients that require more than 325 mg of aspirin per day
- •Patients with a medical condition which requires the continuous use of medication which could interfere with the evaluation of safety or efficacy of valproate : anticonvulsant or anticoagulant therapy, MAO inhibitors, zidovudine
- •Patients having received any depot neuroleptic within six weeks prior to baseline
- •Patients who received antidepressant drugs within 5 days before baseline and patients who received fluoxetine within 20 days
- •Patients judged by the investigator to have serious risk of suicide
- •Patients necessitating an Electro Convulsive Therapy
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
If the daily dose does not exceed 1000 mg, Depakine CHRONO can be administered once a day. If the dose is greater than 1000 mg/day, Depakine CHRONO will be administered in a bid regimen: one tablet in the morning and one tablet in the evening.
干预措施: depakine chrono (Drug)
结局指标
主要结局
The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP.
时间窗: D0, D21 and D-end
次要结局
- Percentage of responders defined by a decrease of at least 50% of the CGI-BP.(D0 and D21)
- Time to achieve 50% and 30% improvement in the CGI-BP score.(From randomization to the end of the study)
- Time to a sustained improvement in the CGI-BP.(From randomization to the end of the study)
- Time to antidepressants use.(From randomization to the end of the study)
- Time to drop-out for any reason.(From randomization to the end of the study)
- Safety :Occurrence of any side effect leading to treatment discontinuation.(From inform consent signed until patient's recovery or stabilization)
研究者
研究点 (2)
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