N-acetyl cysteine for depressive symptoms in bipolar disorder - a double blind, randomized, placebo-controlled trial

Berk, Michael, Copolov, David L., Dean, Olivia, Lu, Kristy, Jeavons, Sue, Schapkaitz, Ian, Anderson-Hunt, Murray and Bush, Ashley I. 2008, N-acetyl cysteine for depressive symptoms in bipolar disorder - a double blind, randomized, placebo-controlled trial, Biological psychiatry, vol. 64, no. 6, pp. 468-475.

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Title N-acetyl cysteine for depressive symptoms in bipolar disorder - a double blind, randomized, placebo-controlled trial
Author(s) Berk, Michael
Copolov, David L.
Dean, Olivia
Lu, Kristy
Jeavons, Sue
Schapkaitz, Ian
Anderson-Hunt, Murray
Bush, Ashley I.
Journal name Biological psychiatry
Volume number 64
Issue number 6
Start page 468
End page 475
Total pages 8
Publisher Elsevier
Place of publication Philadelphia, Pa.
Publication date 2008-09-15
ISSN 0006-3223
1873-2402
Keyword(s) bipolar disorder
clinical trial
depression
glutathione
N-acetyl cysteine
neurochemistry
Summary Background: Treatment-resistant subthreshold depression is a major problem in bipolar disorder. Both depression and bipolar disorderare complicated by glutathione depletion. We hypothesized that treatment with N-acetyl cysteine (NAC), a safe, orally bioavailable precursor of glutathione, may improve the depressive component of bipolar disorder.

Methods: A randomized, double-blind, multicenter, placebo-controlled study of individuals (n 75) with bipolar disorder in the maintenance phase treated with NAC (1 g twice daily) adjunctive to usual medication over 24 weeks, with a 4-week washout. The two primary outcomes were the Montgomery Asberg Depression Rating Scale (MADRS) and time to a mood episode. Secondary outcomes included the Bipolar Depression Rating Scale and 11 other ratings of clinical status, quality of life, and functioning.

Results: NAC treatment caused a significant improvement on the MADRS (least squares mean difference [95% confidence interval]: 8.05 [13.16, 2.95], p .002) a n d most secondary scales at end point. Benefit was evident by 8 weeks on the Global Assessment of Functioning Scale and Social and Occupational Functioning Assessment Scale and at 20 weeks on the MADRS. Improvements were lost after washout. There was no effect of NAC on time to a mood episode (log-rank test: p .968) and no significant between-group differences inadverse events. Effect sizes at end point were medium to high for improvements in MADRS and 9 of the 12 secondary readouts.

Conclusions:
NAC appears a safe and effective augmentation strategy for depressive symptoms in bipolar  disorder.
Language eng
Field of Research 119999 Medical and Health Sciences not elsewhere classified
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C1.1 Refereed article in a scholarly journal
Copyright notice ©2008 Society of Biological Psychiatry
Persistent URL http://hdl.handle.net/10536/DRO/DU:30035459

Document type: Journal Article
Collection: School of Medicine
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