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

NCT03369639 | Withdrawn

• 1 other identifier: 2017P001930
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Keywords

late life; THC; depression; anxiety; dronabinol

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Incidence of treatment-emergent adverse effects (Safety)

  Weekly, from baseline prior to first dose for 2 weeks

• Cognition

  At baseline prior to first dose and at 2 weeks

• Efficacy against depression as measured by the GDS

  Weekly, from baseline prior to first dose for 2 weeks

• Efficacy against anxiety as measured by the GAD-7

  Weekly, from baseline prior to first dose for 2 weeks

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years old (inclusive)
• Inpatient on the Older Adult Unit in South Belknap 1 at McLean Hospital
• Initiating dronabinol therapy for the treatment of any Diagnostic and Statistical Manual (DSM) 5 Major Depression or Anxiety Disorder Diagnosis
• Ability to provide informed consent
• Must be fluent in English

You may not qualify if:

• Delirium as determined by the Confusion Assessment Method (CAM)
• Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes
• Seizure disorder
• Diagnosis of bipolar depression, Major depression with psychotic features, schizophrenia, schizoaffective disorder, dementia
• Use of dronabinol or marijuana in the last year
• Prescription of lithium or anticonvulsant medications (except gabapentin)
• Patient currently admitted involuntarily to McLean Hospital

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Brent P Forester, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Geriatric Psychiatry Research Program and Geriatric Mood Disorders Research Program

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 12, 2017
• Study Start: November 28, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (1)