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Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

NCT ID: NCT04105231

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Dual Diagnosis

Keywords

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psychosis cannabis clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cannabidiol

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.

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Cannabidiol oral suspension

Risperidone

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

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Risperidone, encapsulated tablet.

Interventions

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Cannabidiol

Cannabidiol oral suspension

Intervention Type DRUG

Risperidone

Risperidone, encapsulated tablet.

Intervention Type DRUG

Other Intervention Names

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Epidiolex Risperidon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Center for Sleep Medicine

OTHER

Sponsor Role collaborator

Copenhagen University Hospital, Denmark

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Lone Baandrup

OTHER

Sponsor Role lead

Responsible Party

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Lone Baandrup

Head of Clinic

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lone Baandrup, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Services Capital Region in Denmark

Locations

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Center for Neuropsychiatric Schizophrenia Research

Glostrup Municipality, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lone Baandrup, MD, PhD

Role: CONTACT

Phone: 30270879

Email: [email protected]

Facility Contacts

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Jesper Ø Rasmussen, MD

Role: primary

Lone Baandrup, Med.Sc.D

Role: backup

References

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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.

Reference Type DERIVED
PMID: 34391393 (View on PubMed)

Other Identifiers

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2018-004893-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBD-P

Identifier Type: -

Identifier Source: org_study_id