Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
To examine the safety and efficacy of long term administration of aripiprazole as an adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects with major depressive disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are either inpatients or outpatients
- •Patients who have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial
- •Patients diagnosed as having either "296.2x Major Depressive Disorder, Single Episode" or "296.3x Major Depressive Disorder, Recurrent" according to DSM-IV-TR, and for whom the current episode of major depressive disorder has been ongoing for more than 8 weeks.
排除标准
- •Female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation
- •Female patients who are pregnant, possibly pregnant, or breast feeding
- •Patients judged to be unable to tolerate any type of antidepressant treatment (including drugs not being used in the current episode of major depressive disorder), based on treatment history to date
- •Patients who have previously received electro-convulsive therapy
- •Patients who have participated in clinical studies on medical devices or other drugs within the past month
- •Patients at risk of having serious adverse events or developing symptoms that could interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia syndrome overlapping with symptoms of depression), based on previous medical history
- •Patients with a history or a complication of diabetes
- •Patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months)
- •Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome
- •Patients with a history of seizure disorder (epilepsy etc.)
研究组 & 干预措施
1
干预措施: OPC-14597 (Aripiprazole) (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline(Day 1), Week52 or at discontinuation
Change from baseline to Last Observation Carried Forward (LOCF). Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts
次要结局
未报告次要终点