Dual Diagnosis
Conditions
Keywords
psychosis, cannabis, clinical trial
Brief summary
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.
Detailed description
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.
Interventions
DRUGCannabidiol
Cannabidiol oral suspension
DRUGRisperidone
Risperidone, encapsulated tablet.
Sponsors
Lone Baandrup
Danish Center for Sleep Medicine
Copenhagen University Hospital, Denmark
Glostrup University Hospital, Copenhagen
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* ICD-10 diagnosis of schizophrenia (DF20.X), paranoid psychosis (DF22.X), acute/intermittent psychotic disorder (DF23.X), schizoaffective psychosis (DF25.X), other/not specified nonorganic psychotic disorder (DF28/DF29), or cannabis induced psychotic disorder (DF12.5) * PANSS ≥ 60 and score of ≥ 4 on ≥ 2 PANSS-Positive subscale items: Delusions (P1), conceptual disorganization (P2), hallucinatory behaviour (P3), grandiosity (P5), suspiciousness (P6) * Lifetime cannabis use * Age 18-45 years * Female patients of childbearing potential need to utilize a proper method of contraception
Exclusion criteria
* Treatment resistance as defined by treatment (ever) with clozapine * Dependence syndrome of alcohol or psychoactive substances other than cannabis (DF1X.2 other than DF12.2) * Psychotic disorder induced by alcohol or psychoactive substances other than cannabis (DF1X.5 other than DF12.5) * Treatment with a long-acting injectable antipsychotic within the past month (or corresponding to the usual interval between two injections) * Treatment with an oral antipsychotic within the past 7 days * Use of self-administered CBD products during the trial * Patients involuntarily admitted * Pregnancy or lactation * Severe physical illness that might influence the ability to comply with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychotic symptoms | 7 weeks follow-up | Positive and Negative Syndrome Scale (PANSS) positive subscale, range 7-49. A measure of symptom severity. Higher values are worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline) | 7 weeks follow-up | Timeline follow back method |
| Cannabis use by self-reported days of cannabis use per week, since last study visit. | 7 weeks follow-up | Timeline follow back method |
| Amount of cannabis use per day, self-reported, since last study visit. | 7 weeks follow-up | PSYSCAN cannabis questionnaire# 6-8 |
| Response | 7 weeks follow-up | Response defined by PANSS total 25 percentile changes |
| Remission | 7 weeks follow-up | 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. |
| Global illness severity | 7 weeks follow-up | 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'). |
| Psychosocial functioning | 7 weeks follow-up | Personal and Social Performance Scale (PSP). Higher is better, range 1-100. |
| Neurocognitive functioning | 7 weeks follow-up | Brief Assessment of Cognition in Schizophrenia (BACS). Neurocognitive Test Battery. One composite score and six subscales. |
| Subjective well-being | 7 weeks follow-up | Subjective Well-being under Neuroleptics Scale (SWN). A measure of health-related quality of life. |
| Circadian rest-activity cycle | 7 weeks follow-up | Actigraphy. A wrist-worne device that measures kinetic energy. |
| Subjective sleep quality | 7 weeks follow-up | Pittsburgh Sleep Quality Index (PSQI). One total score, seven subscales. |
| Objective sleep evaluation | 7 weeks follow-up | Polysomnography (PSG). A measure of objective sleep variables |
| Metabolomics | 7 weeks follow-up | Markers for cannabinoids, dopamine and serotonin and their precursors and metabolites in the blood |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORLone Baandrup, MD, PhD
Mental Health Services Capital Region in Denmark
Outcome results
None listed