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Due to prohibitively high drug cost, physicians were not prescribing the drug.
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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from the Mood Disorder inpatient unit within the Division of Geriatric Psychiatry at McLean Hospital. These older patients will have a diagnosis of major depression and/or anxiety and have agreed to begin dronabinol treatment after recommendation by the attending physician.
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| Name | Affiliation | Role |
|---|---|---|
| Brent P Forester, MD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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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 |