Observational Study of Dronabinol Treatment for Depression and/or Anxiety in Older Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy against depression as measured by the MADRS
研究概览
简要总结
This is an observational study evaluating the safety and efficacy of dronabinol for the treatment of anxiety and/or depression in older adults. Participants who are prescribed dronabinol as part of a voluntary inpatient stay in McLean's Division of Geriatric Psychiatry will be interviewed about their mood and cognition on a weekly basis while on dronabinol.
详细描述
Recently there has been renewed interest in potential alternative medical applications of cannabis/THC and medical marijuana is now legalized in 23 states and the District of Columbia. Acute effects of THC can include subjective feelings of euphoria, relaxation, and sedation, and clinicians noted that THC is well tolerated for its approved indications. Given these subjective effects and relatively benign safety profile, some physicians have used dronabinol (synthetic THC) "off-label" to treat depression and/or anxiety.
The investigators are doing this research to better understand how effective dronabinol treatment is when prescribed for depression and/or anxiety in older patients. The investigators also want to find out if dronabinol is safe to take without causing too many side effects. Dronabinol is is approved by the U.S. Food and Drug Administration (FDA) to treat loss of appetite in chemotherapy patients, but dronabinol is not approved by the FDA to treat depression and/or anxiety. Through research questionnaires on mood and cognition, the investigators can gather information that will help demonstrate how effective dronabinol treatment is at treating depression and/or anxiety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-89 years old (inclusive)
- •Inpatient on the Older Adult Unit in South Belknap 1 at McLean Hospital
- •Initiating dronabinol therapy for the treatment of any Diagnostic and Statistical Manual (DSM) 5 Major Depression or Anxiety Disorder Diagnosis
- •Ability to provide informed consent
- •Must be fluent in English
排除标准
- •Delirium as determined by the Confusion Assessment Method (CAM)
- •Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes
- •Seizure disorder
- •Diagnosis of bipolar depression, Major depression with psychotic features, schizophrenia, schizoaffective disorder, dementia
- •Use of dronabinol or marijuana in the last year
- •Prescription of lithium or anticonvulsant medications (except gabapentin)
- •Patient currently admitted involuntarily to McLean Hospital
结局指标
主要结局
Efficacy against depression as measured by the MADRS
时间窗: Weekly, from baseline prior to first dose for 2 weeks
Assessed via the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS score ranges from 0 (least depressed) to 60 (most depressed).
Efficacy against anxiety as measured by the HAM-A
时间窗: Weekly, from baseline prior to first dose for 2 weeks
Assessed via the Hamilton Anxiety Rating Scale (HAM-A). The HAM-A score ranges from 0 (no present anxiety) to 56 (maximum anxiety score).
次要结局
- Incidence of treatment-emergent adverse effects (Safety)(Weekly, from baseline prior to first dose for 2 weeks)
- Efficacy against anxiety as measured by the GAD-7(Weekly, from baseline prior to first dose for 2 weeks)
- Efficacy against depression as measured by the GDS(Weekly, from baseline prior to first dose for 2 weeks)
- Cognition(At baseline prior to first dose and at 2 weeks)
研究者
Brent Forester
Director, Geriatric Psychiatry Research Program and Geriatric Mood Disorders Research Program
Mclean Hospital