Study of Dronabinol Treatment for Depression and/or Anxiety in Older Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Study of Dronabinol Treatment for Depression and/or Anxiety in Older Patients

Conditions
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Depression, Anxiety

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy against depression as measured by the MADRS | Assessed via the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS score ranges from 0 (least depressed) to 60 (most depressed). | Weekly, from baseline prior to first dose for 2 weeks | 
| Efficacy against anxiety as measured by the HAM-A | Assessed via the Hamilton Anxiety Rating Scale (HAM-A). The HAM-A score ranges from 0 (no present anxiety) to 56 (maximum anxiety score). | Weekly, from baseline prior to first dose for 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse effects (Safety) | Assessed by tracking and recording of adverse events and serious adverse events, and interviews about drug effects | Weekly, from baseline prior to first dose for 2 weeks | 
| Cognition | Assessed by administration of the Montreal Cognitive Assessment (MoCA) at baseline and after 2 weeks of dronabinol. MoCA score ranges from 0 (most cognitively impaired) to 30 (least impaired). | At baseline prior to first dose and at 2 weeks | 
| Efficacy against depression as measured by the GDS | Assessed by administration of the Geriatric Depression Scale (GDS). The GDS score ranges from 0 (least depressed) to 15 (most depressed). | Weekly, from baseline prior to first dose for 2 weeks | 
| Efficacy against anxiety as measured by the GAD-7 | Assessed by administration of the Generalized Anxiety Disorder--7 (GAD-7) scale. The GAD-7 score ranges from 0 (no anxiety) to 21 (highest, severe anxiety). | Weekly, from baseline prior to first dose for 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late life, depression, dronabinol, anxiety, THC