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Dual DiagnosisPhase 2NCT04105231

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

A Phase 2 study testing Cannabidiol and Risperidone in people with Dual Diagnosis, run by Lone Baandrup at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Dual Diagnosis
What is being tested?
Cannabidiol and Risperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteDenmark
Study dates
1 Jun 2021to 31 Mar 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients involuntarily admitted
  • Pregnancy or lactation
  • Severe physical illness that might influence the ability to comply with the protocol

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center for Neuropsychiatric Schizophrenia Research

    Glostrup Municipality, 2600

Other trials in Denmark

About this study

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.

Read the detailed description

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
Dual Diagnosis
Being tested
Cannabidiol, Risperidone
Keywords
psychosis, cannabis, clinical trial
Medical subject headings
Psychotic Disorders, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabidiolDrug

    Also called Epidiolex

    Cannabidiol oral suspension

  • RisperidoneDrug

    Also called Risperidon

    Risperidone, encapsulated tablet.

Study groups in NCT04105231
Study groupRoleWhat they receive
CannabidiolExperimentalCannabidiol (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.
Receives: Drug: Cannabidiol
RisperidoneActive comparatorRisperidone (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
Receives: Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychotic symptoms

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

    Measured: 7 weeks follow-up

Secondary outcomes (13)

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

    Timeline follow back method

    Measured: 7 weeks follow-up

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

    Timeline follow back method

    Measured: 7 weeks follow-up

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

    PSYSCAN cannabis questionnaire# 6-8

    Measured: 7 weeks follow-up

  4. Response

    Response defined by PANSS total 25 percentile changes

    Measured: 7 weeks follow-up

  5. 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.

    Measured: 7 weeks follow-up

  6. 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').

    Measured: 7 weeks follow-up

  7. Psychosocial functioning

    Personal and Social Performance Scale (PSP). Higher is better, range 1-100.

    Measured: 7 weeks follow-up

  8. Neurocognitive functioning

    Brief Assessment of Cognition in Schizophrenia (BACS). Neurocognitive Test Battery. One composite score and six subscales.

    Measured: 7 weeks follow-up

  9. Subjective well-being

    Subjective Well-being under Neuroleptics Scale (SWN). A measure of health-related quality of life.

    Measured: 7 weeks follow-up

  10. Circadian rest-activity cycle

    Actigraphy. A wrist-worne device that measures kinetic energy.

    Measured: 7 weeks follow-up

  11. Subjective sleep quality

    Pittsburgh Sleep Quality Index (PSQI). One total score, seven subscales.

    Measured: 7 weeks follow-up

  12. Objective sleep evaluation

    Polysomnography (PSG). A measure of objective sleep variables

    Measured: 7 weeks follow-up

  13. Metabolomics

    Markers for cannabinoids, dopamine and serotonin and their precursors and metabolites in the blood

    Measured: 7 weeks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2019
  2. Study start1 Jun 2021
  3. Primary completion25 Nov 2025
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04105231
Sponsor's protocol ID
CBD-P
Other IDs
2018-004893-84, 2018
Status last verified
Jan 2026
First submitted
22 Sep 2019
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be available. In addition, the study protocol will be available. Data will be available after publication of planned primary and secondary analyses. There will be no end date for availability of data. Individual participant data will be available for meta-analysis. Proposals should be directed to: lone.baandrup@regionh.dk. To gain access, data requestors will need to sign a data access agreement.

Publications

  • 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.

    PubMed 34391393

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabidiol and Risperidone in people with Dual Diagnosis, run by Lone Baandrup at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychotic symptoms (time frame: 7 weeks follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04105231, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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