A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Change in MADRS Total Score
研究概览
简要总结
This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.
The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.
详细描述
The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •130 male or female patients, 18-65 years of age, with:
- •DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI)
- •MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization
- •Inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following > six weeks of therapy at adequate doses (according to the US label) of any non-tricyclic, non-MAOI antidepressant medication
排除标准
- •Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to enrollment
- •DSM-IV Axis II diagnoses that significantly impact the current psychiatric status
- •Current MDD episode lasting > 12 months
- •Electroconvulsive therapy within the preceding 6 months
- •Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment
- •Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24)
- •Risk of suicide as defined by MADRS item 10 score > 4
- •Prior failure to respond to asenapine
- •Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline
- •Hepatic impairment and history of low WBC, by medical history and interview.
研究组 & 干预措施
Placebo 1-4 tablets daily
Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
干预措施: Placebo 1-4 tablets daily (Drug)
Asenapine 5-20 mg daily
Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability
干预措施: Asenapine 5-20 mg daily (Drug)
结局指标
主要结局
Change in MADRS Total Score
时间窗: Baseline, 6 weeks
The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
次要结局
- Clinical Remission Rate(6 weeks)
- Study Completion Rate(6 weeks)
- Rates of Sustained Remission(2, 4, 6 weeks)
- Clinical Response Rate(Baseline, 6 weeks)