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

Phase

N/A

Condition

Panic Disorders

Anxiety Disorders

Depression

Treatment

N/A

Clinical Study ID

NCT03369639

2017P001930

Ages 50-89
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 StatisticalManual (DSM) 5 Major Depression or Anxiety Disorder Diagnosis
Ability to provide informed consent
Must be fluent in English

Exclusion

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 confoundassessment 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

Study Design

November 28, 2017

October 01, 2018

Study 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.

Connect with a study center

McLean Hospital
Belmont, Massachusetts 02478
United States
Site Not Available

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