Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
关键词
抽象
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.
日期
| 最后验证: | 07/31/2015 |
| 首次提交: | 08/16/2012 |
| 提交的预估入学人数: | 08/16/2012 |
| 首次发布: | 08/20/2012 |
| 上次提交的更新: | 08/30/2015 |
| 最近更新发布: | 09/30/2015 |
| 首次提交结果的日期: | 06/28/2015 |
| 首次提交质量检查结果的日期: | 08/30/2015 |
| 首次发布结果的日期: | 09/30/2015 |
| 实际学习开始日期: | 09/30/2012 |
| 预计主要完成日期: | 04/30/2014 |
| 预计完成日期: | 05/31/2014 |
状况或疾病
干预/治疗
Drug: Asenapine 5-20 mg daily
Drug: Placebo 1-4 tablets daily
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 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 | Drug: Asenapine 5-20 mg daily 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID |
| Placebo Comparator: 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 | Drug: Placebo 1-4 tablets daily One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: -130 male or female patients, 18-65 years of age, with: 1. DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI) 2. MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization 3. 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 Exclusion Criteria: 1. 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 2. DSM-IV Axis II diagnoses that significantly impact the current psychiatric status 3. Current MDD episode lasting > 12 months 4. Electroconvulsive therapy within the preceding 6 months 5. Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment 6. Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24) 7. Risk of suicide as defined by MADRS item 10 score > 4 8. Prior failure to respond to asenapine 9. Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline 10. Hepatic impairment and history of low WBC, by medical history and interview. |
结果
主要结果指标
1. Change in MADRS Total Score [Baseline, 6 weeks]
次要成果指标
1. Study Completion Rate [6 weeks]
2. Clinical Response Rate [Baseline, 6 weeks]
3. Clinical Remission Rate [6 weeks]
4. Rates of Sustained Remission [2, 4, 6 weeks]
