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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03369639
Recruitment Status : Withdrawn (Due to prohibitively high drug cost, physicians were not prescribing the drug.)
First Posted : December 12, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Brent Forester, 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.

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Dronabinol




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).



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369639


Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
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Principal Investigator: Brent P Forester, MD Mclean Hospital

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Responsible Party: Brent Forester, Director, Geriatric Psychiatry Research Program and Geriatric Mood Disorders Research Program, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03369639     History of Changes
Other Study ID Numbers: 2017P001930
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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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:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists