Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004893-84 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Danish Center for Sleep Medicine | OTHER |
| Copenhagen University Hospital, Denmark | OTHER |
| Glostrup University Hospital, Copenhagen | OTHER |
| University of Copenhagen |
Not provided
Not provided
Not provided
Not provided
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.
People with psychosis and comorbid cannabis use are particularly difficult to treat because cannabis use worsens psychotic symptoms and increases the risk that a first-episode psychosis will progress to schizophrenia. It is the THC (tetrahydrocannabinol) content in cannabis that aggravates psychotic symptoms whereas the CBD content has potential therapeutic effects. This trial investigates treatment with CBD (without THC) versus risperidone (an antipsychotic agent) in people with psychosis and lifetime use of cannabis. We hypothesize that CBD will ameliorate psychotic symptoms and reduce the frequency of cannabis use to a larger extent than risperidone. Sleep disturbances are often a limiting factor in the treatment of psychosis, and it is also examined how CBD affects objective and subjective sleep quality as well as circadian rest-activity cycles. Based on previous studies investigating CBD as monotherapy in patients with schizophrenia, it is expected that CBD will be associated with fewer adverse events than risperidone.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Cannabidiol oral suspension |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline) | Timeline follow back method | 7 weeks follow-up |
| Cannabis use by self-reported days of cannabis use per week, since last study visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), discontinuation due to AEs, and serious adverse events (SAEs) | Self-report | From baseline to 2 weeks after end of treatment |
| Extrapyramidal and other side effects | Udvalget for Kliniske Undersoegelser (UKU) short version A clinician-rated scale to assess antipsychotic side effects |
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lone Baandrup, MD, PhD | Mental Health Services Capital Region in Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neuropsychiatric Schizophrenia Research | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34391393 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Data will be available after publication of planned primary and secondary analyses. No end date.
Proposals should be directed to: lone.baandrup@regionh.dk. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2025 | Jan 25, 2026 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Risperidone | Drug | Risperidone, encapsulated tablet. |
|
|
Timeline follow back method
| 7 weeks follow-up |
| Amount of cannabis use per day, self-reported, since last study visit. | PSYSCAN cannabis questionnaire# 6-8 | 7 weeks follow-up |
| Response | Response defined by PANSS total 25 percentile changes | 7 weeks follow-up |
| Remission | Symptomatic remission is defined according to the Andreasen et al remission criteria. The criteria define symptomatic remission as a rating of no more than mild in four core positive and four core negative symptoms on the Positive and Negative Syndrome Scale (P1, P2 P3, N1, N4, N6, G5, G9,) that is sustained for ≥6 months. Because of the duration of this study, the requirement of 6 month will not be considered. | 7 weeks follow-up |
| Global illness severity | Global illness severity is assessed with the Clinical Global Impression Scale (CGI). We will use the severity (CGI-S) at baseline and improvement (CGI-I) scores of the CGI at the following visits. Response will be defined as much improved or better on the CGI-I. The main item 'severity of illness' is measured on a 7-point Likert scale (from 1 'normal, not at all ill' to 7 'among the most extremely ill patients'). | 7 weeks follow-up |
| Psychosocial functioning | Personal and Social Performance Scale (PSP). Higher is better, range 1-100. | 7 weeks follow-up |
| Neurocognitive functioning | Brief Assessment of Cognition in Schizophrenia (BACS). Neurocognitive Test Battery. One composite score and six subscales. | 7 weeks follow-up |
| Subjective well-being | Subjective Well-being under Neuroleptics Scale (SWN). A measure of health-related quality of life. | 7 weeks follow-up |
| Circadian rest-activity cycle | Actigraphy. A wrist-worne device that measures kinetic energy. | 7 weeks follow-up |
| Subjective sleep quality | Pittsburgh Sleep Quality Index (PSQI). One total score, seven subscales. | 7 weeks follow-up |
| Objective sleep evaluation | Polysomnography (PSG). A measure of objective sleep variables | 7 weeks follow-up |
| Metabolomics | Markers for cannabinoids, dopamine and serotonin and their precursors and metabolites in the blood | 7 weeks follow-up |
| 7 weeks follow-up |
| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |