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. 2021 Oct 8;2021(10):CD011611. doi: 10.1002/14651858.CD011611.pub3

Ellegaard 2019.

Study characteristics
Methods Double‐blind, randomised, placebo‐controlled trial
Participants Diagnosis: DSM‐IV bipolar disorder (I, II) on MINI, MADRS score ≥ 18; current acute depressive episode
N: 80
Age: N‐acetylcysteine (NAC) group M = 43.7 (SD = 10.0), placebo group M = 43.0 (SD = 10.2)
Sex: NAC group = 65% female, placebo group = 52.5% female
Baseline depression severity: N‐acetylcysteine (NAC) group MADRS M = 30.1 (SD = 7.9), placebo group M = 28.8 (SD = 7.1)
Interventions Participants were randomised to receive 20 weeks of treatment with either NAC 3 mg/day or placebo in addition to treatment as usual (medications not specified).
Outcomes Response
Remission
Treatment emergent AEs
MADRS
Bech‐Rafaelsen Melancholia Scale
YMRS
WHO‐Five Well‐being index
Global Assessment of Functioning scale
Global Assessment of Symptoms scale
CGI‐S
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were quote:“randomly allocated to NAC or placebo add‐on according to a pre‐constructed computer‐generated randomization list divided into blocks of eight.”
Allocation concealment (selection bias) Low risk Participants were Quote:“randomly allocated to NAC or placebo add‐on according to a pre‐constructed computer‐generated randomization list divided into blocks of eight.”
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No evidence of blind being tested
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not enough information provided.
Incomplete outcome data (attrition bias)
All outcomes Low risk CONSORT diagram included, similar drop‐out rates in both arms.
Selective reporting (reporting bias) Low risk Protocol available, outcomes reported as expected.
Other bias Unclear risk None identified.