Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

The efficacy of adjunctive N-acetylcysteine in acute bipolar depression: A randomized placebo-controlled study

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Polygenic predisposition to breast cancer and the risk of coronary artery disease

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Clinical, Physiologic, and Behavioral Evaluation of Permanently Catheterized NMRI Mice

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. A multisystem composite biomarker as a preliminary diagnostic test in bipolar disorder

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

OBJECTIVE: To investigate the efficacy of adjunctive N-acetylcysteine (NAC) for the treatment of acute bipolar depression.

METHOD: A randomized, double-blind, multicentre, placebo-controlled trial including adult subjects diagnosed with bipolar disorder, currently experiencing a depressive episode. Participants were treated with 3 g/day NAC or placebo as an adjunctive to standard treatment for 20 weeks, followed by a 4-week washout where the blinding was maintained. The primary outcome was the mean change in the Montgomery Asberg Depression Rating Scale (MADRS) score over the 20-week treatment phase. Linear Mixed Effects Repeated Measures (LMERM) was used for analysing the primary outcome.

RESULTS: A total of 80 subjects were included. The mean MADRS score at baseline was 30.1 and 28.8 in participants randomized to NAC and placebo, respectively. Regarding the primary outcome measure, the between-group difference (NAC vs. placebo) was 0.5, which was statistically non-significant (95% CI: -7.0-5.9;p = 0.88). All findings regarding secondary outcomes were statistically or clinically insignificant.

LIMITATIONS: The study had a placebo response rate of 55.6% - high placebo response rates are associated with failure to separate from placebo.

CONCLUSIONS: Based on our primary outcome measure, we could not confirm previous studies showing a therapeutic effect of adjunctive NAC treatment on acute bipolar depression. Further studies with larger samples are needed to elucidate if specific subgroups could benefit from adjunctive NAC treatment.

Original languageEnglish
JournalJournal of Affective Disorders
Volume245
Pages (from-to)1043-1051
Number of pages9
ISSN0165-0327
DOIs
Publication statusPublished - 15 Feb 2019

ID: 56643149