Evidence map›Paper›PMID 22891797›Full record

Trial reportBMC medicine2012

Maintenance N-acetyl cysteine treatment for bipolar disorder: a double-blind randomized placebo controlled trial.

Michael Berk, Olivia M Dean, Sue M Cotton, Clarissa S Gama, Flavio Kapczinski, Brisa Fernandes, Kristy Kohlmann, Susan Jeavons, Karen Hewitt, Kirsteen Moss and 6 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
5.9field-weighted citation impact, top 3% 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

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Review
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  11. Intracellular Signaling Cascades in Bipolar Disorder.Current topics in behavioral neurosciences · 2021
    Review
  12. Review
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  15. Article
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  17. Review
  18. Article
  19. Mitochondrial Agents for Bipolar Disorder.The international journal of neuropsychopharmacology · 2018
    Review
  20. 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

16 authors at 8 institutions in 3 countries.

Michael BerkDeakin University, School of Medicine, Barwon Health, P.O. Box 291, Geelong, 3220, Australia. mikebe@barwonhealth.org.au
Olivia M Dean
Sue M Cotton
Clarissa S Gama
Flavio Kapczinski
Brisa Fernandes
Kristy Kohlmann
Susan Jeavons
Karen Hewitt
Kirsteen Moss
Christine Allwang
Ian Schapkaitz
Heidi Cobb
Ashley I Bush
Seetal Dodd
Gin S Malhi
University of Melbourne · AUUniversidade Federal do Rio Grande do Sul · BRMental Health Research Institute · AURoyal North Shore Hospital · AUBarwon Health · AUHospital de Clínicas de Porto Alegre · BROrygen Youth Health · AUUniversity of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundN-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder.

methodThe efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes.

resultsThere was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures.

conclusionsThere were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations.

trial registrationThe trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).

Indexed as

AcetylcysteineAdultAntidepressive AgentsBipolar DisorderFemaleHumansMaintenance ChemotherapyMaleMiddle AgedNew ZealandPlacebosQuality of LifeSecondary PreventionTime FactorsTreatment OutcomeAcetylcysteineAntidepressive AgentsPlacebos

Identifiers

PMID22891797
PMCPMC3482580
OpenAlexW2105920925

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.