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) |
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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 |
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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. |