Evidence map›Paper›PMID 27629871›Full record

Trial reportBMC psychiatry2016

N-acetylcysteine (NAC) in schizophrenia resistant to clozapine: a double blind randomised placebo controlled trial targeting negative symptoms.

Susan L Rossell, Paul S Francis, Cherrie Galletly, Anthony Harris, Dan Siskind, Michael Berk, Kiymet Bozaoglu, Frances Dark, Olivia Dean, Dennis Liu and 5 more

Open access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 10% 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.

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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Antioxidants (Basel, Switzerland) · 2022
    Review
  10. SubchronicAntioxidants (Basel, Switzerland) · 2021
    Article
  11. Article
  12. Article
  13. Protocol and Rationale: A 24-week Double-blind, Randomized, Placebo Controlled Trial of the Efficacy of AdjunctiveClinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2019
    Article
  14. Article
  15. Review
  16. Review
  17. Targeting the Immune System with Pharmacotherapy in Schizophrenia.Current treatment options in psychiatry · 2017
    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

15 authors at 10 institutions in 1 country.

Susan L RossellCentre for Mental Health, Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, VIC, Australia. srossell@swin.edu.au.
Paul S FrancisCentre for Chemistry and Biotechnology, School of Life & Environmental Sciences, Deakin University, Geelong, VIC, Australia.
Cherrie GalletlyPsychiatry Department, University of Adelaide, Adelaide, South Australia, Australia.
Anthony HarrisDiscipline of Psychiatry, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
Dan SiskindSchool of Medicine, University of Queensland, Brisbane, QLD, Australia.
Michael BerkIMPACT Strategic Research Centre, Barwon Health, Deakin University, Geelong, VIC, Australia.
Kiymet BozaogluBaker IDI Heart & Diabetes Institute, Melbourne, VIC, Australia.
Frances DarkMetro South Addiction and Mental Health Service, Brisbane, QLD, Australia.
Olivia DeanIMPACT Strategic Research Centre, Barwon Health, Deakin University, Geelong, VIC, Australia.
Dennis LiuPsychiatry Department, University of Adelaide, Adelaide, South Australia, Australia.
Denny MeyerCentre for Mental Health, Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, VIC, Australia.
Erica NeillSt Vincent's Mental Health Service, St Vincent's Hospital, Melbourne, VIC, Australia.
Andrea PhillipouSt Vincent's Mental Health Service, St Vincent's Hospital, Melbourne, VIC, Australia.
Jerome SarrisARCADIA Mental Health Research Group, Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, VIC, Australia.
David J CastleSt Vincent's Mental Health Service, St Vincent's Hospital, Melbourne, VIC, Australia. david.castle@svha.org.au.
Barwon Health · AUSt Vincent's Hospital Melbourne · AUSwinburne University of Technology · AUThe University of Adelaide · AUThe University of Melbourne · AUBaker Heart and Diabetes Institute · AUDeakin University · AUMetro South Health · AUThe University of Queensland · AUThe University of Sydney · AU

Funding

NICHD NIH HHS N01 AA021004
6 · The paper itself

Abstract

backgroundClozapine is an effective treatment for a proportion of people with schizophrenia (SZ) who are resistant to the beneficial effects of other antipsychotic drugs. However, anything from 40-60 % of people on clozapine experience residual symptoms even on adequate doses of the medication, and thus could be considered 'clozapine resistant'. Agents that could work alongside clozapine to improve efficacy whilst not increasing the adverse effect burden are both desired and necessary to improve the lives of individuals with clozapine-resistant SZ. N-Acetylcysteine (NAC) is one such possible agent. Previous research from our research group provided promising pilot data suggesting the efficacy of NAC in this patient population. The aim of the study reported here is to expand this work by conducting a large scale clinical trial of NAC in the treatment of clozapine-resistant SZ.

methodsThis study is an investigator initiated, multi-site, randomised, placebo-controlled trial. It aims to include 168 patients with clozapine-resistant SZ, divided into an intervention group (NAC) and a control group (placebo). Participants in the intervention group will receive 2 g daily of NAC. The primary outcome measures will be the negative symptom scores of the Positive and Negative Syndrome Scale (PANSS). Secondary outcome measures will include: changes in quality of life (QoL) as measured by the Lancashire Quality of Life Profile (LQoLP) and cognitive functioning as measured by the total score on the MATRICS. Additionally we will examine peripheral and cortical glutathione (GSH) concentrations as process outcomes. DISCUSSION: This large scale clinical trial will investigate the efficacy of NAC as an adjunctive medication to clozapine. This trial, if successful, will establish a cheap, safe and easy-to-use agent (NAC) as a 'go to' adjunct in patients that are only partly responsive to clozapine.

trial registrationAustralian and New Zealand Clinical Trials Registration Number: Current Randomised Controlled Trial ACTRN12615001273572 . The date of registration 23 November 2015.

Indexed as

ClozapineSchizophrenic PsychologyAcetylcysteineAdolescentAdultAgedAntipsychotic AgentsAustraliaDouble-Blind MethodDrug ResistanceFemaleFollow-Up StudiesFree Radical ScavengersHumansMaleMiddle AgedAcetylcysteineAntipsychotic AgentsClozapineFree Radical ScavengersBiomarkersClozapineCognitionN-AcetylcysteineNegative SymptomsSchizophrenia

Identifiers

PMID27629871
PMCPMC5024434
OpenAlexW2520829703

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.