Does Dual Therapy Hasten Antidepressant Response?
关键词
抽象
描述
Depression is a major public health problem due to its prevalence and accompanying dysfunction and costs. Depression is undertreated, but even when treatment is adequate and effective, sources of delay in current pharmacologic strategies include: mechanistic delays, those related to the physiologic and behavioral effects of antidepressants; dosing delays in identifying the effective dose; and programmatic delays in identifying an effective agent using sequential monotherapy. This study will randomize 240 patients with Diagnostic and Statistical Manual, 4th Edition (DSM-IV) Major Depressive Disorder (MDD) to 12 week double blind treatment with combined escitalopram and bupropion or each antidepressant administered alone to evaluate whether combined escitalopram and bupropion result in more rapid remission and greater over-all remission than monotherapy. Preclinical and clinical studies suggest that bupropion might prevent one mechanistic delay inherent in escitalopram monotherapy. Rapid dose escalation may counter dosing delays. The simultaneous use of two known antidepressant medications may alleviate programmatic delays inherent in usual sequential monotherapy. Six months follow up and careful assessment of adverse events will address tolerability, acceptability, sustainability, and pharmacoeconomic concerns. If successful, this study might have a significant impact on clinical practice, public health, and depression's cost consequences.
日期
| 最后验证: | 08/31/2017 |
| 首次提交: | 08/19/2007 |
| 提交的预估入学人数: | 08/19/2007 |
| 首次发布: | 08/21/2007 |
| 上次提交的更新: | 09/04/2017 |
| 最近更新发布: | 10/03/2017 |
| 首次提交结果的日期: | 10/05/2016 |
| 首次提交质量检查结果的日期: | 09/04/2017 |
| 首次发布结果的日期: | 10/03/2017 |
| 实际学习开始日期: | 07/31/2007 |
| 预计主要完成日期: | 06/30/2011 |
| 预计完成日期: | 02/29/2012 |
状况或疾病
干预/治疗
Drug: escitalopram
Drug: bupropion
Drug: escitalopram + bupropion
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: escitalopram + bupropion escitalopram plus bupropion extra long (XL) as dual treatment (i.e., this is not a SINGLE treatment arm; all patients assigned this arm received both medications) | Drug: escitalopram + bupropion same dosing schedule as for monotherapy |
| Active Comparator: escitalopram escitalopram monotherapy | Drug: escitalopram 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted |
| Active Comparator: bupropion bupropion extra long (XL) monotherapy | Drug: bupropion 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted |
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: 1. Men and women ages 18-65 2. Major Depressive Disorder as primary diagnosis 3. Physically healthy 4. Signs informed consent 5. Montgomery Asberg Depression Rating Scale (MADRS) >= 22 Exclusion Criteria: 1. Bipolar Disorder (ie, Bipolar I, Bipolar II, Bipolar NOS) 2. Life-time history of psychosis 3. Current (ie, last 6 months) drug or alcohol abuse or dependence (except nicotine) 4. Currently taking effective antidepressant medication 5. Prior adequate treatment in current depressive episode with a selective serotonin re-uptake inhibitor (SSRI), bupropion (BUP) or bupropion (BUP) + a selective serotonin re-uptake inhibitor (SSRI) ("adequate" is defined as >= 4 weeks taking >= 2/3 Physician's Desk Reference (PDR) maximal dose 6. Most recent antidepressant was within 5 weeks for fluoxetine and 1 week for all others 7. Currently taking a medication contraindicated with either study medication 8. Life time history of anorexia or bulimia 9. Life time history of seizure or known increased seizure risk (e.g., history of significant brain trauma, taking pro-convulsant medication, known anatomical brain lesion) 10. Currently taking psychoactive medication deemed to be necessary (including but not limited anticonvulsants, antidepressants, antipsychotics, steroids, and B-blockers); occasional use of hypnotics (ie, less than three times per week) will be allowed 11. Unstable medical condition (ie, condition not adequately stabilized for >= 3 months) 12. Prior intolerance to escitalopram (ESC) or bupropion (BUP) 13. Inadequate understanding of English (for US site; Canadian site permits French fluency) 14. Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods |
结果
主要结果指标
1. Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7 [12 weeks]
次要成果指标
1. Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12 [12 weeks]
2. Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17) [12 weeks]
3. Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score [12 weeks]
4. Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF) [12 weeks]
