Non-affective psychosis and lifetime cannabis use MedDRA version: 20.0 Level: LLT Classification code 10037234 Term: Psychosis System Organ Class: 100000004873 MedDRA version: 21.1 Level: LLT Classification code 10070996 Term: Cannabis use System Organ Class: 100000004869
Conditions
Interventions
Product Name: Cannabidiol
Pharmaceutical Form: Capsule
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
Mental Health Center Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
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 non-organic psychotic disorder (DF28/DF29), or cannabis induced psychotic disorder (DF12.5) - Lifetime use of cannabis, i.e. used at least once - Age 18-45 years - Female participants with reproductive potential need to utilize a proper method of contraception (the pill, vaginal ring, hormonal patch, intrauterine device, contraceptive injection) or two-barrier methods, i.e. cervical cape and condom - For female participants a negative pregnancy test is required before inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 oral antipsychotics 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 |
|---|---|
| Main Objective: To examine the efficacy of Cannabidiol (CBD) for treatment of psychosis ;Secondary Objective: To examine how CBD affects use of cannabis, cannabis cessation for current users, negative symptoms, global illness severity, anxiety, psychosocial functioning, subjective well-being, cognition, sleep and circadian rhythmicity ;Primary end point(s): Psychotic symptoms: PANSS positive subscale score ;Timepoint(s) of evaluation of this end point: Seven weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Frequency and quantity of cannabis use, including desire/urge to use: WHO Assist 3.0, cannabis questionnaire# 6-8 - Cannabis cessation (self-reported) for current cannabis users (exploratory outcome) - Negative symptoms: PANSS negative subscale score - Response/remission/exacerbation defined by PANSS 25 percentile changes - Global illness severity: Clinical Global Impression Scale schizophrenia (CGI-SCH)26 - Anxiety: Hamilton Anxiety Scale (HAM-A) - Psycho social functioning: Personal and social performance scale (PSP) - Neurocognitive functioning: Brief Assessment of Cognition in Schizophrenia (BACS) - Quality of life: Subjective Well-Being under Neuroleptics Scale (SWN) - Circadian sleep-wake cycle: Actigraphy assessment - Subjective sleep quality: Pittsburgh Sleep Quality Index (PSQI) - Objective sleep evaluation: Polysomnography (PSG) - Metabolomics ;Timepoint(s) of evaluation of this end point: Seven weeks | — |
Countries
Denmark
Contacts
Public ContactLone Baandrup
Mental Health Center Glostrup
Outcome results
None listed