Cannabidiol for treatment of non-affective psychosis and cannabis use

2024-517630-18-00 Phase II and Phase III (Integrated) Ended

Start 8 Oct 2024 · End 2 Dec 2025 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ended
Participants planned 64
Countries 1
Sites 1

Lifetime cannabis use

To examine the efficacy of cannabidiol (CBD) for treatment of psychosis

Key facts

Sponsor
Region Hovedstaden
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Mental Disorders [F03]
Trial duration
8 Oct 2024 → 2 Dec 2025
Decision date (initial)
2024-10-08
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
The Research Foundation of the Capital Region · Alfred Benzon Foundation

External identifiers

EU CT number
2024-517630-18-00
EudraCT number
2018-004893-84

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To examine the efficacy of cannabidiol (CBD) for treatment of psychosis

Secondary objectives 1

  1. To examine how CBD affects use of cannabis, cessat...

Conditions and MedDRA coding

Lifetime cannabis use

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. 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)
  2. PANSS ≥ 60 and score of ≥ 4 on ≥ 2 PANSS-Positive subscale items: Delusions (P1), conceptual disorganization (P2), hallucinatory behaviour (P3), grandiosity (P5), suspiciousness (P6)
  3. Lifetime cannabis use
  4. Age 18-45 years
  5. Female patients of childbearing potential need to utilize a proper method of contraception

Exclusion criteria 9

  1. Treatment resistance as defined by treatment (ever) with clozapine
  2. Dependence syndrome of alcohol or psychoactive substances other than cannabis (DF1X.2 other than DF12.2)
  3. Psychotic disorder induced by alcohol or psychoactive substances other than cannabis (DF1X.5 other than DF12.5)
  4. Treatment with a long-acting injectable antipsychotic within the past month (or corresponding to the usual interval between two injections)
  5. Treatment with an oral antipsychotic within the past 7 days
  6. Use of self-administered CBD products during the trial
  7. Patients involuntarily admitted
  8. Pregnancy or lactation
  9. Severe physical illness that might influence the ability to comply with the protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Severity of psychotic symptoms

Secondary endpoints 12

  1. Frequency and quantity of cannabis use by self-reported days of cannabis use per week and amount of use
  2. Cannabis cessation (for current users), defined as no use during the past two weeks (self-reported)
  3. Total symptom severity
  4. Symptom response and remission
  5. Global severity of illness
  6. Psychosocial functioning
  7. Neurocognitive functioning
  8. Subjective well-being
  9. Circadian sleep-wake cycle
  10. Subjective sleep quality
  11. Objective sleep evaluation
  12. Metabolomics

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Epidyolex 100 mg/ml oral solution

PRD7621461 · Product

Active substance
Cannabidiol
Substance synonyms
CBD
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
29400 mg milligram(s)
Max treatment duration
7 Week(s)
Authorisation status
Authorised
ATC code
N03AX24 — -
Marketing authorisation
EU/1/19/1389/001
MA holder
JAZZ PHARMACEUTICALS IRELAND LTD
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Risperidon ”Krka”, filmovertrukne tabletter

PRD543348 · Product

Active substance
Risperidone
Substance synonyms
3-[2-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]ETHYL]-2-METHYL-6,7,8,9-TETRAHYDROPYRIDO[2,1-B]PYRIMIDIN-4-ONE
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
196 mg milligram(s)
Max treatment duration
7 Week(s)
Authorisation status
Authorised
ATC code
N05AX08 — RISPERIDONE
Marketing authorisation
39407
MA holder
KRKA SVERIGE AB
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 2

Risperidon placebo

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Epidyolex placebo

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

38 Total trials 23 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Region Hovedstaden
Address
Esther Ammundsens Vej 36
City
Copenhagen Nv
Postcode
2400
Country
Denmark

Scientific contact point

Organisation
Psykiatrisk Center Kobenhavn
Contact name
Lone Baandrup

Public contact point

Organisation
Psykiatrisk Center Kobenhavn
Contact name
Lone Baandrup

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ended 64 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ended
Psykiatrisk Center Kobenhavn
Bispebjerg, Esther Ammundsens Vej 36, 2400, Copenhagen Nv

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2024-10-08 2025-12-02

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2024-517630-18-00 7
Recruitment arrangements (for publication) Placeholder document 1
Subject information and informed consent form (for publication) L1_ICF 1
Subject information and informed consent form (for publication) L1_SIS 7
Summary of Product Characteristics (SmPC) (for publication) SPC Epidyolex 1
Summary of Product Characteristics (SmPC) (for publication) SPC Risperidon Krka 1
Synopsis of the protocol (for publication) D1_Protocol synopsis DK_2024-517630-18-00 7

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-12 Denmark Acceptable
2024-10-01
 2024-10-08
2 SUBSTANTIAL MODIFICATION SM-4 2025-03-07 Denmark Acceptable
2025-03-11
 2025-03-11