Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

Phase 2Active Not RecruitingNCT04105231

Lone Baandrup64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dual Diagnosis

Interventions

CannabidiolDRUG

Cannabidiol oral suspension

RisperidoneDRUG

Risperidone, encapsulated tablet.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Neuropsychiatric Schizophrenia Research

Glostrup Municipality, Denmark

Outcomes

Primary Outcomes

Psychotic symptoms

Positive and Negative Syndrome Scale (PANSS) positive subscale, range 7-49. A measure of symptom severity. Higher values are worse.

Time frame: 7 weeks follow-up

Secondary Outcomes

Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline)

Timeline follow back method

Time frame: 7 weeks follow-up

Cannabis use by self-reported days of cannabis use per week, since last study visit.

Timeline follow back method

Time frame: 7 weeks follow-up

Amount of cannabis use per day, self-reported, since last study visit.

PSYSCAN cannabis questionnaire# 6-8

Time frame: 7 weeks follow-up

Response

Response defined by PANSS total 25 percentile changes

Time frame: 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.

Time frame: 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').

Data from ClinicalTrials.gov

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