A Phase 2 interventional study of fsCBD Cannabidiol and bsCBD Cannabidiol in Sleep, Anxiety and Depression, sponsored by University of Colorado, Boulder. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University of Colorado, Boulder · Phase 2, Interventional, and Treatment
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Among 3,709 studies in Depression with a site in United States — 578 open to participants now, 717 under way, 30 of them phase 3. Depression · United States.
Among the 3,709 studies in Depression with a site in United States, this one is the 427th largest by planned enrollment of the 3,316 interventional ones that give a count, is one of 213 that started in 2024, is one of 337 in phase 2, reaches primary completion later than 554 of the 715 other live ones, and was the 3,193rd registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →578 of the 3,709 studies in Depression with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 13–17
NeuroRx, Inc. · Sites in United States
Ages 18–80
Ohio State University · Sites in United States
Ages 21–65
Florida State University · Sites in United States
Ages 18–55 · Healthy volunteers
University of Texas Southwestern Medical Center · Sites in United States
Ages 12–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
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: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,709 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 1 235 · Phase 2 441 · Phase 3 285 · Phase 4 265
First in 1977; this study’s year is marked. 213 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 385 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 72 across the 3,316 interventional studies, 138 across the 371 observational. Of the 2,761 that completed or were terminated, 1,045 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
392 of 3,709 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Boulder is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
University of Colorado, Boulder has 9 studies filed under Depression — fewer than ten, so there is no comparison to draw.
299 of the studies in Depression with a site in United States that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT06922110Phase 3Xenon Pharmaceuticals Inc.An Open-Label Study of Azetukalner in Major Depressive Disorder | 2027-01 |
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT04777357Phase 3AbbVieA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | 2027-03 |
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
Add all 299 to your calendar (.ics) → With an account.
Among the 3,709 studies in Depression with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's planned enrollment of 385 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →University of Colorado, Boulder is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)
Drug: fsCBD Cannabidiol
8 weeks of use of a daily dose of cannabis (200mg CBD)
Drug: bsCBD Cannabidiol
Drug: Placebo
Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Subjective Motor Function
Activities-specific Balance Confidence Scale. Participants asked about confidence in completion of 16 daily tasks without losing balance or becoming unsteady. Responses are on a scale from no confidence to completely confident, with higher aggregate scores meaning higher subjective motor function.
Time frame: Baseline, 4 weeks, 8 weeks
Balance
Dynamic sway (balance) measured via an app on a standard smartphone which will be attached to the participant's waist using a Velcro strap.
Time frame: Baseline, 4 weeks, 8 weeks
Anxiety
Beck Anxiety Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher anxiety. Total scores are between 0-63, where anything above 36 suggest potentially concerning levels of anxiety.
Time frame: Baseline, 4 weeks, 8 weeks
Depression
Beck Depression Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher depression. Total scores are between 0-63, where anything above 40 suggest potentially concerning levels of depression.
Time frame: Baseline, 4 weeks, 8 weeks
Blood Cytokine Levels
Blood cytokine levels will be measured from biological samples. Includes blood levels of cytokine inflammatory markers (IL6, TNF-α, IL-β, and CRP)
Time frame: Baseline, 4 weeks, 8 weeks
Depression/Anxiety
Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.
Time frame: Baseline, 4 weeks, 8 weeks
Drug Effects
Drug Effects Questionnaire (DEQ). Six questions about drug effects with possible answers of "not at all", "somewhat", and "extremely", where higher scores indicate higher drug effects.
Time frame: 4 weeks, 8 weeks
Inhibitory Control
Flanker Inhibitory Control and Attention Task
Time frame: Baseline, 4 weeks, 8 weeks
Cognitive Function
Functional Assessment of Cognitive Function - Cognitive (FACT-Cog). Scores are transformed such that scores range from 0-132 and higher scores indicate a better quality of life/cognitive function.
Time frame: Baseline, 4 weeks, 8 weeks
Pain Intensity and Interference
Brief Pain Inventory - Short Form (BPI - SF). Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain.
Time frame: Baseline, 4 Weeks, 8 Weeks
Cognitive Ability
Digital Symbol Substitution Test (DSST) assesses global cognitive ability
Time frame: Baseline, 4 weeks, 8 weeks
Pain Intensity
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (7-day). Scores are between 1-5, with 1 being no pain and 5 being very severe. Assessed with 2 items as well as current pain.
Time frame: Baseline, 4 weeks, 8 weeks
Change in Condition
Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.
Time frame: 4 weeks, 8 weeks
Sleep Disturbance
PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 4a. Scores are separated between the first question (sleep quality) and the remaining 7 questions. For the first question, scores are between 1 and 5, with 1 being very poor sleep quality and 5 being very good sleep quality. The remaining 7 questions are scored individually on a scale of 1--5; for some questions, higher scores mean less disturbance, and for others, a higher score means more disturbance.
Time frame: Baseline, 4 weeks, 8 weeks
Sleep-Related Impairment
PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment 4a. Scores are between 4 and 20, with higher scores indicating more sleep-related impairment
Time frame: Baseline, 4 weeks, 8 weeks
Memory
Rey auditory verbal learning test assesses verbal memory.
Time frame: Baseline, 4 weeks, 8 weeks
Polypharmacy-Pain Medications
Use of pain medications
Time frame: Baseline, 4 weeks, 8 weeks
Polypharmacy-Psychiatric Medications
Use of psychiatric medications
Time frame: Baseline, 4 weeks, 8 weeks
Polypharmacy-Sleep Medications
Use of sleep medications
Time frame: Baseline, 4 weeks, 8 weeks
Strength and Endurance
Leg strength and endurance measured with 30-second chair stand task. Participants are asked to stand up from a chair as many times as possible for 30 seconds.
Time frame: Baseline, 4 weeks, 8 weeks
Sleep Quality
PSQI (Pittsburgh Sleep Quality Index) measures quality and patterns of sleep. Global scores range from 0-21 with higher scores indicating worse sleep quality.
Time frame: Baseline, 4 weeks, 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Aug 2028, 51 months after the start.
Of 143 non-industry phase 2 interventional studies under Depression, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's planned 51 months is above that.
Counting every sponsor, half of 196 studies reached it within 31 months; a quarter within 18 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Colorado, Boulder