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

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression, Anxiety

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the Mood Disorder inpatient unit within the Division of Geriatric Psychiatry at McLean Hospital. These older patients will have a diagnosis of major depression and/or anxiety and have agreed to begin dronabinol treatment after recommendation by the attending physician.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Investigators: Principal Investigator: Brent P Forester, MD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: depression; anxiety; THC; dronabinol; late life
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 2017P001930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No