An observational study in Depression, Anxiety, sponsored by Mclean Hospital. Withdrawn at 1 site in United States. Open to participants aged 50 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Mclean Hospital · Observational
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Among 41 studies in Depression by Mclean Hospital — 8 open to participants now, 10 under way, none of them phase 3. Depression · Mclean Hospital.
Among the 41 studies in Depression by Mclean Hospital, this one is the 10th largest by enrollment of the 10 observational ones that give a count, is one of 3 that started in 2017, is one of 10 observational ones, and was the 26th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →8 of the 41 studies in Depression by Mclean Hospital are open now, in 1 country. Recruiting first, the newest first:
Mclean Hospital · Sites in United States
Ages 18+ · Healthy volunteers
Mclean Hospital · Sites in United States
Ages 18+
Mclean Hospital · Sites in United States
Ages 18+
Mclean Hospital · Sites in United States
Ages 13–15 · Women only · Healthy volunteers
Mclean Hospital · Sites in United States
Ages 18–80
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 50 Years to 89 Years · all sexes · no healthy volunteers.
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41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 6 · Phase 3 2
First in 2004; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 68 across the 31 interventional studies, 112 across the 10 observational. Of the 28 that completed or were terminated, 11 (39%) have results posted.
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Mclean Hospital is the lead sponsor of 185 studies on the registry; 31 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
6 of the studies in Depression by Mclean Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07868627Mclean HospitalNovel and Conventional Interventions for Cognitive and Emotional Flexibility in Patient Trauma | 2026-12-01 |
| NCT06876129Mclean HospitalPharmacologic Augmentation of TMS for Depression With D-serine | 2026-12-26 |
| NCT07785102Mclean HospitalSingle Day of Ultra-accelerated TMS With a Single Dose of NRX-101 | 2026-12-31 |
| NCT04325529Mclean HospitalPharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.2 (Stress Manipulation) | 2027-04-30 |
| NCT04713722Mclean HospitalEarly Life Stress and Depression: Molecular and Functional Imaging | 2027-04-30 |
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Among the 41 studies in Depression by Mclean Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: 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).
Time frame: Weekly, from baseline prior to first dose for 2 weeks
Incidence of treatment-emergent adverse effects (Safety)
Assessed by tracking and recording of adverse events and serious adverse events, and interviews about drug effects
Time frame: Weekly, from baseline prior to first dose for 2 weeks
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).
Time frame: At baseline prior to first dose and at 2 weeks
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).
Time frame: Weekly, from baseline prior to first dose for 2 weeks
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).
Time frame: Weekly, from baseline prior to first dose for 2 weeks
Ran from Nov 2017 to primary completion in Oct 2018, 10 months.
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This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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