Placebo-Controlled, Double-Blind, Parallel Group-Comparison 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
- 586
- 主要终点
- Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive disorder.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 74 Years（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
- •Patients with a HAM-D17 total score of 18 or more
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 antidpressant 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
2
Titration dose
干预措施: Aripiprazole (Titrated dose) (Drug)
3
Placebo
干预措施: Placebo (Drug)
1
Fixed dose
干预措施: Aripiprazole (Fixed dose) (Drug)
结局指标
主要结局
Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group. 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
- MADRS Response Rate(Baseline (the end of the SSRI/SNRI treatment period), at completion of administration)
- Mean Change in Sheehan Disability Scale (SDISS)(Baseline (the end of the SSRI/SNRI treatment period), at completion of administration)