E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-affective psychosis and lifetime cannabis use |
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E.1.1.1 | Medical condition in easily understood language |
Patients affected by both psychosis and lifetime cannabis use |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037234 |
E.1.2 | Term | Psychosis |
E.1.2 | System Organ Class | 100000004873 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070996 |
E.1.2 | Term | Cannabis use |
E.1.2 | System Organ Class | 100000004869 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To examine the efficacy of Cannabidiol (CBD) for treatment of psychosis
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Psychotic symptoms: PANSS positive subscale score
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |