A Phase 4, 8-week, Double-blind, Randomized Study Comparing Switching to Duloxetine or Escitalopram in Patients With Major Depressive Disorder and Residual Apathy in the Absence of Depressed Mood
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8
研究概览
简要总结
The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual apathy in the absence of depressed mood.
详细描述
Apathy is reported by up to 30% of patients with major depressive disorder (MDD) and is hypothesized to be a treatment emergent adverse effect associated with selective serotonin reuptake inhibitor medication. While there is currently no consistent method for treating apathy among psychiatrists, it has been proposed that switching MDD patients to antidepressant medications containing both serotonin and norepinephrine, such as duloxetine, may reduce the incidence and severity of apathy in these patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or citalopram) for major depressive disorder
- •Females of child-bearing potential to test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control
- •Apathy Evaluation Scale - Clinician Rated Version (AES-C) total score >30 at screening and randomization.
- •Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤15 and Item 1 (apparent sadness) score of <2 at screening and randomization.
- •Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel.
排除标准
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
- •Have previously completed or withdrawn from this study or any other study investigating duloxetine.
- •Have had previous lack of response to an adequate trial of duloxetine within the past 12 months or escitalopram at any time.
- •Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis of mania, bipolar disorder, treatment resistant depression or psychosis; or current suicide risk
- •Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR),substance abuse or dependence within the 6 months
- •Presence of an Axis II disorder
- •Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or the potential need to use an MAOI during the study
- •Positive urine drug screen for any substance of abuse or excluded medication.
- •Are pregnant or breast-feeding.
- •Serious medical illness, requires hospitalization during the study
- •Have uncontrolled narrow-angle glaucoma.
- •Have acute liver injury or severe cirrhosis
- •Abnormal thyroid stimulating hormone (TSH) concentration
- •Amphetamines, dopaminergic medications or modafinil within 14 days prior to randomization or potential need to use such medications during the study or within 14 days of discontinuation of study drug.
研究组 & 干预措施
Duloxetine
干预措施: Duloxetine (Drug)
Escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8
时间窗: Baseline, 8 weeks
The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment\*visit, baseline, and baseline\*visit.
次要结局
- Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8(Baseline, 8 weeks)
- Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8(Baseline, 8 weeks)
- Patient's Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8(8 weeks)
- Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8(Baseline, 8 weeks)
- Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8(Baseline, 8 weeks)
- Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8(Baseline, 8 weeks)
- Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8(Baseline, 8 weeks)
- Percentage of Participants Who Relapsed During 8 Weeks(Baseline through 8 weeks)
- Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks(Baseline through 8 weeks)
- Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks(Baseline through 8 weeks)