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

• ClinicalTrials.gov Identifier: NCT03369639
• Recruitment Status: Withdrawn
• First Posted: December 12, 2017
• Last Update Posted: July 31, 2019
• Sponsor: Mclean Hospital
• Information provided by (Responsible Party): Brent Forester, Mclean Hospital

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Observational Study of Dronabinol Treatment for Depression and/or Anxiety in Older Patients
• Actual Study Start Date: November 28, 2017
• Actual Primary Completion Date: October 1, 2018
• Actual Study Completion Date: October 1, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Efficacy against depression as measured by the MADRS [ Time Frame: 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).
2. Efficacy against anxiety as measured by the HAM-A [ Time Frame: 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 :

1. Incidence of treatment-emergent adverse effects (Safety) [ Time Frame: 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
2. Cognition [ Time Frame: 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).
3. Efficacy against depression as measured by the GDS [ Time Frame: 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).
4. Efficacy against anxiety as measured by the GAD-7 [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Massachusetts

McLean Hospital

Belmont, Massachusetts, United States, 02478

Sponsors and Collaborators

Mclean Hospital

Investigators

• Principal Investigator: Brent P Forester, MD; Mclean Hospital

More Information

• Responsible Party: Brent Forester, Director, Geriatric Psychiatry Research Program and Geriatric Mood Disorders Research Program, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT03369639
• Other Study ID Numbers: 2017P001930
• First Posted: December 12, 2017
• Last Update Posted: July 31, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brent Forester, Mclean Hospital:

late life; THC; depression; anxiety; dronabinol

Additional relevant MeSH terms:

Depression; Depressive Disorder; Anxiety Disorders; Behavioral Symptoms; Mood Disorders; Mental Disorders