Stimulant Enhancement of Well-Being Therapy for Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items
研究概览
简要总结
This study aims to identify a novel enhancement strategy for residual symptoms of major depressive disorder (MDD) Dopamine (DA) has been viewed as a "pleasure neurotransmitter" for over 30 years. Yet recent data from animal and human studies suggest that dopamine has greater effects on "wanting" than on "liking." Therefore, the investigators of this study have hypothesized that amphetamine/d-amphetamine (AMPH), a medication which increases dopamine transmission in the reward centers of the brain, may have a more powerful antidepressant effect in combination with well-being therapy (WBT), a specific type of cognitive-behavioral therapy, which helps individuals with depression to increase their contact with natural rewards and decrease reward-interfering thoughts.
The investigators will test their hypothesis by randomizing 40 individuals with residual symptoms of depression, already taking an antidepressant that affects serotonin (e.g. Prozac, Paxil), to 8 weeks of treatment with either WBT in combination with AMPH, or WBT with pill placebo. The effectiveness of each treatment will be measured using a reliable scale, called the Hamilton Depression Rating Scale.
The investigators have also hypothesized that people assigned to the stimulant/WBT group will have greater improvements in functioning, well-being, and positive affectivity than those the people assigned to the WBT/placebo group.
详细描述
The study will have 11 visits occur over 8 weeks with study visits scheduled weekly or biweekly.
Detailed Description:
The study visit occurrences are as follows:
- Week 0- Screening Visit
- Week 1- Baseline Visit
- Week 2- one phone visit and one clinic visit in one week
- Week 3- one phone visit and one clinic visit in one week
- Week 4- one visit in one week
- Week 5- one visit in one week
- Week 6- one visit in one week
- Week 7- one visit in one week
- Week 8- one visit in one week
WBT description Four licensed therapists, who have been trained and certified in WBT, will provide weekly sessions of 30 to 50 minutes in duration. Therapists will follow the procedures outlined in the WBT manual. The initial sessions (weeks 0-2) will be focused on identifying and contextualizing episodes of well-being. The intermediate sessions (weeks 3-5) will be focused on modifying cognitions and behaviors, which lead to premature interruption of well-being, and optimizing cognitions and behaviors, which have been idiographically linked to enhanced well-being. Final sessions (weeks 6-8) will apply the Psychological Well-Being scales (PWB) to refine treatment according to Ryff's dimensions of well-being. Additional principles and techniques of WBT include reappraisal, mood-charting, scheduling of activities, shaping, problem-solving, and assertiveness training.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
WBT + amphetamine/dextroamphetamine
In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
干预措施: Amphetamine/dextroamphetamine (Drug)
WBT + amphetamine/dextroamphetamine
In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.
干预措施: Well-being therapy (Behavioral)
WBT + placebo
In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
干预措施: Placebo (Drug)
WBT + placebo
In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.
干预措施: Well-being therapy (Behavioral)
结局指标
主要结局
Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items
时间窗: Baseline and visit 11/week 8 of treatment, or between baseline and early termination visit.
Comparison between the 2 groups of the percentage of subjects in remission, as defined by a HAM-D-17 score of \< 8 at endpoint visit 11/week 8 of treatment, or early termination visit.
Change in Hamilton-Depression Rating Scale(SIGH-D)-31 Item
时间窗: Baseline to Visit 11 (which is week 8 of treatment) or Early Termination Visit.
Comparison between the 2 groups of the percentage of participants who have responded to the treatment (response is defined here as a 50% or greater improvement on the HAM-D-31 score) between Baseline and Visit 11 or Early Termination Visit.
次要结局
- Change in Functioning on Short Form-12(SF-12)(Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.)
- Change in Psychological Well-being Scale (PWB)(Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.)
- Change in the Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.)
- Change in Behavioral Inhibition/Activation Scale (BIS/BAS)(Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.)
- Change in Positive and Negative Affective Scale (PANAS)(Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.)
研究者
Maren Nyer
Clinical Psychologist
Massachusetts General Hospital