Study of Dronabinol Treatment for Depression and/or Anxiety in Older Patients
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|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Recruitment Status : Withdrawn (Due to prohibitively high drug cost, physicians were not prescribing the drug.)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 : July 31, 2019
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|Condition or disease|
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|
|Actual Enrollment :||0 participants|
|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|
- 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).
- 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).
- 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
- 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).
- 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).
- 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).
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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|
- 50-89 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
- 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
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
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Brent P Forester, MD||Mclean Hospital|
|Responsible Party:||Brent Forester, Director, Geriatric Psychiatry Research Program and Geriatric Mood Disorders Research Program, Mclean Hospital|
|Other Study ID Numbers:||
|First Posted:||December 12, 2017 Key Record Dates|
|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|