Buprenorphine for Late-Life Treatment Resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- UKU Side Effect Rating Scale
研究概览
简要总结
The goals of this pilot study are to gather data about the safety and clinical effect of low-dose buprenorphine in older adults with treatment resistant depression.
详细描述
We are recruiting 20 participants for this pilot study. Subjects are recruited from either:
- An ongoing study of Late-Life Depression(MH083660; PI: Reynolds) who did not meet research response criteria; and 2) community-dwelling individuals, at least 50 years old, who have tried at least two FDA-approved antidepressant medications at therapeutic doses each for at least 6 weeks, and who are currently in an episode of major depression.
Overview of intervention: To guide future placebo-controlled work, at this preliminary stage of research we will collect data about both buprenorphine (BUP) 1) augmentation pharmacotherapy, and 2) monotherapy. Subjects recruited from the community will have the buprenorphine prescribed as augmentation to any currently prescribed antidepressant medication.
BUP 0.2 mg will be used for the first week. The first dose will be administered at the clinic under the supervision of the PI. Because peak plasma levels occur 60 minutes after ingestion, subjects will be re-assessed after 1 hour for safety. Participants will be seen weekly for eight weeks to assess progress and monitor intervention-emergent side effects. Dosing increases will be guided by antidepressant response (e.g., continued MADRS scores > 10 will trigger an increase dose of BUP) and our protocolized use of the Frequency, Intensity, and Burden of Side Effect Rating (FIBSER) Scale score. For example, a score of 5 to 7 on the FIBSER will trigger additional assessment of side effects and require justification for increasing the dose, while a score of > 7 will signal no increase in dose, although specific side effects should be reviewed in detail before a final determination, including review if the UKU Side Effects Rating Scale.
We will increase the dose by 0.2 mg/week up to 1.6 mg/day based on MADRS and FIBSER scores. Every time the dose is increased, the first ingestion of the higher dose will be monitored in the clinic as described above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 50 years
- •Major depressive disorder
- •Non-responder to at least 2 FDA-approved antidepressants prescribed at a therapeutic dose, each for at least 6 weeks, or is a depression non-responder from an ongoing study of late-life depression at our research clinic.
排除标准
- •Concomitant use of strong or moderate CYP3A4 inhibitor.
- •Refusal to stop all opioids.
- •Refusal to discontinue all alcohol.
- •Refusal to discontinue benzodiazepines other than the equivalent of lorazepam 2 mg/day prescribed at a stable dose for at least the past 2 weeks.
- •Hepatic impairment (AST/ALT > 1.5 times upper normal.
- •Lung disease requiring supplemental oxygen.
- •Estimated creatinine clearance <30 mL/min.
- •Inability to provide informed consent.
- •Depressive symptoms not severe enough (i.e., MADRS < 10) at the baseline assessment.
- •Dementia.
- •Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
- •Abuse of or dependence on alcohol or other substances within the past 3 months.
- •Meets criteria for history of abuse or dependence upon opioids.
- •High risk for suicide.
- •Contraindication to buprenorphine.
- •Inability to communicate in English.
- •Non-correctable clinically significant sensory impairment.
- •Unstable medical illness.
- •Subjects taking psychotropic medications that cannot be safely tapered and discontinued prior to study initiation.
研究组 & 干预措施
Buprenorphine
Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
UKU Side Effect Rating Scale
时间窗: 8 weeks
measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects
Heart Rate
时间窗: 8 weeks
Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome
Montgomery Asberg Depression Rating Scale
时间窗: 8 weeks
measure of depression severity theoretical scale range 0-60 Lower values represent better outcome
Blood Pressure
时间窗: 8 weeks
Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.
次要结局
- Brief Symptom Inventory -- Anxiety Subscale(8 weeks)
- Positive and Negative Affect Scale(8 weeks)
- Pain Numeric Rating Scale (20 Item)(8 weeks)
研究者
Jordan F. Karp
Associate Professor
University of Pittsburgh