NCT00060905已完成3 期
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Abbott18 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2003年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 18
- 主要终点
- Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current primary diagnosis of bipolar I disorder, mania or mixed type
- •Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score >= 18
- •Hospitalized no more than 7 days at time of Screening or in process of being admitted
- •History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement
排除标准
- •History of schizophrenia or schizoaffective disorder
- •Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- •Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)
- •Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
- •Had first manic episode after age 60
- •Has ever taken clozapine
- •Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug
- •Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
- •History of active alcohol or substance dependence within past 3 months.
- •History of failed treatment on adequate valproate therapy for bipolar disorder
- •Has taken Depakote (DR or ER) regularly over the last 30 days
- •Has serious violent, homicidal, or suicidal ideation
结局指标
主要结局
Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
次要结局
- Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
- BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.
研究者
研究点 (18)
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