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

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.

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