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

Withdrawn

• Conditions: Depression, Anxiety

• Registration Number: NCT03369639
• Lead Sponsor: Mclean Hospital

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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study Start: 2017-11-28
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy against depression as measured by the MADRS	Weekly, from baseline prior to first dose for 2 weeks	Assessed via the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS score ranges from 0 (least depressed) to 60 (most depressed).
Efficacy against anxiety as measured by the HAM-A	Weekly, from baseline prior to first dose for 2 weeks	Assessed via the Hamilton Anxiety Rating Scale (HAM-A). The HAM-A score ranges from 0 (no present anxiety) to 56 (maximum anxiety score).

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse effects (Safety)	Weekly, from baseline prior to first dose for 2 weeks	Assessed by tracking and recording of adverse events and serious adverse events, and interviews about drug effects
Efficacy against anxiety as measured by the GAD-7	Weekly, from baseline prior to first dose for 2 weeks	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).
Efficacy against depression as measured by the GDS	Weekly, from baseline prior to first dose for 2 weeks	Assessed by administration of the Geriatric Depression Scale (GDS). The GDS score ranges from 0 (least depressed) to 15 (most depressed).
Cognition	At baseline prior to first dose and at 2 weeks	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).

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States