NCT04105231|Active Not RecruitingPhase 2
Loading search results
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
64
1 country
1
Study Start
June 1, 2021
Actual (reported)Primary Completion
November 25, 2025
Actual (reported)Study Completion
March 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This trial examines the efficacy of cannabidiol (CBD) versus risperidone for treatment of psychosis in patients with non affective-psychosis and lifetime use of cannabis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2019
Actual (reported)September 26, 2019
Actual (reported)June 1, 2021
Actual (reported)November 25, 2025
Actual (reported)March 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Psychotic symptoms
Positive and Negative Syndrome Scale (PANSS) positive subscale, range 7-49. A measure of symptom severity. Higher values are worse.
7 weeks follow-up
Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline)
7 weeks follow-up
Cannabis use by self-reported days of cannabis use per week, since last study visit.
7 weeks follow-up
Amount of cannabis use per day, self-reported, since last study visit.
7 weeks follow-up
Response
7 weeks follow-up
Remission
7 weeks follow-up
Adverse events (AEs), discontinuation due to AEs, and serious adverse events (SAEs)
From baseline to 2 weeks after end of treatment
Extrapyramidal and other side effects
7 weeks follow-up
Cannabidiol (Epidiolex®) (oral suspension)100 mg/ml dosed as 3 ml in the morning for 4 days, then increased to 3 ml in the morning and 3 ml in the evening, equivalent to CBD 300 mg BID, with a total treatment duration of 7 weeks. AND Risperione placebo, encapsulated tablet.
Risperidone (encapsulated tablet) dosed as 2 mg in the morning for 4 days, then increased with 2 mg in the morning and 2 mg in the evening, with a total treatment duration of 7 weeks AND Cannabidiol placebo, oral suspension
Cannabidiol oral suspension
Risperidone, encapsulated tablet.
Center for Neuropsychiatric Schizophrenia Research
Glostrup Municipality, 2600, Denmark
Rasmussen JO, Jennum P, Linnet K, Glenthoj BY, Baandrup L. Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2021 Aug 14;21(1):404. doi: 10.1186/s12888-021-03395-9.
Lone Baandrup, MD, PhD
Mental Health Services Capital Region in Denmark
First Submitted
September 22, 2019
First Posted
September 26, 2019
Study Start
June 1, 2021
Actual (reported)Primary Completion
November 25, 2025
Actual (reported)RCT of CBD for Anxiety in Advanced Breast Cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
March 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 27, 2026
Record last verified: 2026-01
Individual participant data will be available. In addition, the study protocol will be available. Data will be available after publication of planned primary and secondary analyses. There will be no end date for availability of data. Individual participant data will be available for meta-analysis. Proposals should be directed to: lone.baandrup@regionh.dk. To gain access, data requestors will need to sign a data access agreement.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: