NCT03369639

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Depression, Anxiety

Timeline

• Start date: 2017-11-28
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-12-12
• Last updated: 2019-07-31

Locations

1 site across 1 country: United States