Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 742
- 试验地点
- 5
- 主要终点
- Psychological Well-Being
研究概览
简要总结
The purpose of this research study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD).
详细描述
Older adult participants with treatment-resistant depression will be randomly assigned to a Step 1 medication strategy.
- Adding aripiprazole to current antidepressant medication
- Adding bupropion to current antidepressant medication
- Replacing current antidepressant medication with bupropion
If depression is not relieved at the end of 10 weeks, or if participants do not qualify for Step 1, participants will be randomly assigned to a Step 2 medication strategy:
- Adding lithium to current antidepressant medication
- Replacing current antidepressant medication with nortriptyline
All medication strategies will be offered in collaboration with participants' own physicians with the the research team providing support and guidance.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 60 and older
- •Current Major Depressive Disorder (MDD)
- •Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length
- •Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher
排除标准
- •Inability to provide informed consent
- •Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
- •High risk for suicide and unable to be managed safely in the clinical trial
- •Contraindication to proposed study medications, as determined by study physician including history of intolerance or non-response to proposed medications.
- •Non-correctable, clinically significant sensory impairment interfering with participation
- •Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.
- •Moderate to severe substance or alcohol use disorder
研究组 & 干预措施
Aripiprazole Augmentation
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
干预措施: Aripiprazole Augmentation (Drug)
Bupropion Augmentation
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
干预措施: Bupropion Augmentation (Drug)
Switch to Bupropion
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
干预措施: Switch to bupropion (Drug)
Lithium Augmentation
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
干预措施: Lithium Augmentation (Drug)
Switch to Nortriptyline
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
干预措施: Switch to nortriptyline (Drug)
结局指标
主要结局
Psychological Well-Being
时间窗: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, SD=10).
Number of Participants With Remission From Depression
时间窗: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms.
Serious Adverse Events
时间窗: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Life threatening illness, hospitalization, or need of medical care.
次要结局
未报告次要终点
研究者
Eric Lenze
Professor of Psychiatry
Washington University School of Medicine