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

NCT ID: NCT03369639

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-28
• Study Completion Date: 2018-10-01

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. 50-89 years old (inclusive)

2. Inpatient on the Older Adult Unit in South Belknap 1 at McLean Hospital

3. Initiating dronabinol therapy for the treatment of any Diagnostic and Statistical Manual (DSM) 5 Major Depression or Anxiety Disorder Diagnosis

4. Ability to provide informed consent

5. Must be fluent in English

Exclusion Criteria

1. Delirium as determined by the Confusion Assessment Method (CAM)

2. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes

3. Seizure disorder

4. Diagnosis of bipolar depression, Major depression with psychotic features, schizophrenia, schizoaffective disorder, dementia

5. Use of dronabinol or marijuana in the last year

6. Prescription of lithium or anticonvulsant medications (except gabapentin)

7. Patient currently admitted involuntarily to McLean Hospital

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brent Forester

Director, Geriatric Psychiatry Research Program and Geriatric Mood Disorders Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brent P Forester, MD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2017P001930

Identifier Type: -

Identifier Source: org_study_id