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.
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.
Study Type
OBSERVATIONAL
McLean Hospital
Belmont, Massachusetts, United States
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).
Time frame: 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).
Time frame: Weekly, from baseline prior to first dose for 2 weeks
Incidence of treatment-emergent adverse effects (Safety)
Assessed by tracking and recording of adverse events and serious adverse events, and interviews about drug effects
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Weekly, from baseline prior to first dose for 2 weeks
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