Evidence map›Paper›PMID 39359160›Full record

ArticleBJPsych open2024

Protocol for Cancloz: multicentre randomised, placebo-controlled, double-blind, parallel-group adaptive trial of cannabidiol for clozapine-resistant schizophrenia.

Dan Siskind, Claudia Bull, Shuichi Suetani, Nicola Warren, Anastasia Suraev, Iain McGregor, Steve Kisely, Veronica De Monte, Mike Trott, Manju Shine and 9 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BJPsych open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

19 authors.

Dan SiskindFaculty of Medicine, The University of Queensland, Woolloongabba, Australia; Metro South Addiction and Mental Health Services, Woolloongabba, Australia; Queensland Centre for Mental Health Research, Wacol, Australia; and Queensland Brain Institute, The University of Queensland, Brisbane, Australia.ORCID https://orcid.org/0000-0002-2072-9216
Claudia BullFaculty of Medicine, The University of Queensland, Woolloongabba, Australia; and Queensland Centre for Mental Health Research, Wacol, Australia.ORCID https://orcid.org/0000-0003-4064-652X
Shuichi SuetaniQueensland Centre for Mental Health Research, Wacol, Australia; Queensland Brain Institute, The University of Queensland, Brisbane, Australia; Institute for Urban Indigenous Health, Windsor, Australia; and School of Medicine and Dentistry, Griffith University, Southport, Australia.ORCID https://orcid.org/0000-0002-2487-5691
Nicola WarrenFaculty of Medicine, The University of Queensland, Woolloongabba, Australia; Metro South Addiction and Mental Health Services, Woolloongabba, Australia; and Queensland Centre for Mental Health Research, Wacol, Australia.ORCID https://orcid.org/0000-0002-0805-1182
Anastasia SuraevLambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, Australia.
Iain McGregorLambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, Australia.
Steve KiselyFaculty of Medicine, The University of Queensland, Woolloongabba, Australia; and Metro South Addiction and Mental Health Services, Woolloongabba, Australia.ORCID https://orcid.org/0000-0003-4021-2924
Veronica De MonteMetro South Addiction and Mental Health Services, Woolloongabba, Australia.
Mike TrottFaculty of Medicine, The University of Queensland, Woolloongabba, Australia; and Queensland Centre for Mental Health Research, Wacol, Australia.ORCID https://orcid.org/0000-0001-5978-3407
Manju ShineMetro South Addiction and Mental Health Services, Woolloongabba, Australia.
Vikas MoudgilMetro North Mental Health, Royal Brisbane Women's Hospital, Herston, Australia.
Gail RobinsonMetro North Mental Health, The Prince Charles Hospital, Chermside, Australia.
Stephen ParkerFaculty of Medicine, The University of Queensland, Woolloongabba, Australia; School of Medicine and Dentistry, Griffith University, Southport, Australia; and Metro North Mental Health, Royal Brisbane Women's Hospital, Herston, Australia.
Ravikumar KrishnaiahCommunity Mental Health, Gold Coast University Hospital, Southport, Australia.
Terry StedmanWest Moreton Division of Mental Health and Specialised Services, Wacol, Australia.
Allan DrummondGoodna Community Mental Health, Goodna, Australia; and Integrated Mental Health Centre, Ipswich, Australia.
Sarah MedlandQIMR Berghofer Medical Research Institute, Herston, Australia.
Ravi IyerMAGNET: Mental Health Australia General Clinical Trials Network, Geelong, Australia; and Swinburne University of Technology, Hawthorn, Australia.
Andrea BakerQueensland Centre for Mental Health Research, Wacol, Australia.

Funding

PA Research Foundation RSS_2021_020
6 · The paper itself

Abstract

backgroundAlthough clozapine is the most effective antipsychotic for people with treatment-resistant schizophrenia (TRS), only 40% of people with TRS respond, and there is limited evidence for augmentation agents. Cannabidiol (CBD) reduces positive symptoms in individuals with schizophrenia, but no trials have specifically examined its efficacy in those with clozapine-resistant schizophrenia.

aimsTo examine the clinical efficacy of CBD augmentation in people with clozapine-resistant schizophrenia.

methodThis is a 12-week randomised, placebo-controlled, double-blind, parallel-group trial (registration number: ACTRN12622001112752). We will recruit 88 individuals with clozapine-resistant schizophrenia, randomised (1:1) to 1000 mg daily CBD versus placebo. Eligible individuals will be aged between 18 and 64 years, fulfil DSM-IV criteria for schizophrenia or schizoaffective disorder, have a total PANSS (Positive and Negative Syndrome Scale) score ≥60, have received oral clozapine for at least 18 weeks and have a clozapine level of >350 ng/mL. Interim analyses will be conducted at 25, 50 and 75% recruitment; these will also provide an opportunity to reallocate participants dependent on conditional power. The primary endpoint will be the difference in PANSS positive scores at the end of week 12. Secondary endpoints include depression, anxiety, sleep, quality of life, alcohol consumption, change in weight and metabolic syndrome components, and neurocognitive measures, as well as safety and tolerability. DISCUSSION: Novel treatments for clozapine-resistant schizophrenia are urgently needed. If found to be effective, CBD may have a role as a novel and safe adjunct to clozapine.

Indexed as

cannabidiolclozapinerandomised controlled trialSchizophreniatreatment-resistant schizophrenia

Identifiers

PMID39359160
PMCPMC11536212

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.