Evidence map›Paper›PMID 34391393›Full record

ArticleBMC psychiatry2021

Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial.

Jesper Østrup Rasmussen, Poul Jennum, Kristian Linnet, Birte Y Glenthøj, Lone Baandrup

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04105231 (Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04105231 phase2active not recruitingnot on this map

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

TypeinterventionalSponsorLone BaandrupRan2021 to 2026Enrolled64ConditionsDual DiagnosisArmsCannabidiol, Risperidone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Jesper Østrup RasmussenCentre for Neuropsychiatric Schizophrenia Research and Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, Mental Health Centre Glostrup, Nordstjernevej 41, 2600, Glostrup, Denmark. jesper.oestrup.rasmussen@regionh.dk.ORCID 0000-0003-4713-4199
Poul JennumDanish Centre for Sleep Medicine, Department of Clinical Neurophysiology, University of Copenhagen, Rigshospitalet-Glostrup, Copenhagen, Denmark.
Kristian LinnetFaculty of Health and Medical Sciences, Section of Forensic Chemistry, Department of Forensic Medicine, University of Copenhagen, Copenhagen, Denmark.
Birte Y GlenthøjCentre for Neuropsychiatric Schizophrenia Research and Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, Mental Health Centre Glostrup, Nordstjernevej 41, 2600, Glostrup, Denmark.
Lone BaandrupCentre for Neuropsychiatric Schizophrenia Research and Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, Mental Health Centre Glostrup, Nordstjernevej 41, 2600, Glostrup, Denmark.
University of Copenhagen · DKGlostrup Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCannabis use is an important risk factor for development of psychosis and further transition to schizophrenia. The prevalence of patients with psychosis and comorbid cannabis use (dual diagnosis) is rising with no approved specialized pharmacological treatment option. Cannabidiol, a constituent of the Cannabis sativa plant, has potential both as an antipsychotic and as a cannabis substituting agent. The aim of this study is to evaluate the efficacy of cannabidiol versus a first-choice second-generation antipsychotic (risperidone) in patients with early psychosis and comorbid cannabis use.

methodsThe study is a phase II randomized, double-blinded, parallel-group, active-comparator clinical trial. We plan to include 130 patients aged between 18 and 64 years with a recent diagnosis of psychosis, comorbid cannabis use, and currently not treated with antipsychotics. The participants will be randomized to seven weeks of treatment with either cannabidiol 600 mg (300 mg BID) or risperidone 4 mg (2 mg BID). Participants will undergo clinical assessment after 1, 3, 5 and 7 weeks, telephone assessment the weeks in between, and a safety visit two weeks after end of treatment. The primary outcomes are cessation of cannabis use (self-reported) and psychotic symptom severity. The secondary outcomes include frequency and quantity of cannabis use, global illness severity, psychosocial functioning, subjective well-being, cognition, sleep, circadian rhythmicity, and metabolomics. DISCUSSION: The results of this trial can potentially contribute with a new treatment paradigm for patients suffering from dual diagnosis.

trial registrationClinicalTrials.gov , NCT04105231 , registered April 23rd, 2021.

Indexed as

Antipsychotic AgentsCannabidiolCannabisPsychotic DisordersAdolescentAdultHumansMiddle AgedRandomized Controlled Trials as TopicRisperidoneYoung AdultAntipsychotic AgentsCannabidiolRisperidoneAntipsychotic medicationCannabidiolCannabisDual diagnosisPsychosisRandomized clinical trialSchizophreniaTHC

Identifiers

PMID34391393
PMCPMC8364057
OpenAlexW3194038607

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.