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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03369639
• Other study ID #: 2017P001930
• Status: Withdrawn
• Start date: November 28, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: July 2019
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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