title: The efficacy of N-acetylcysteine as an adjunctive treatment in bipolar depression: an open label trial.
abstract: BACKGROUND
  Evidence is accumulating to support the presence of redox dysregulation in a number of psychiatric disorders, including bipolar disorder. This dysregulation may be amenable to therapeutic intervention. Glutathione is the predominant non-enzymatic intracellular free radical scavenger in the brain, and the most generic of all endogenous antioxidants in terms of action. N-acetylcysteine (NAC) is a glutathione precursor that effectively replenishes brain glutathione. Given the failure of almost all modern trials of antidepressants in bipolar disorder to demonstrate efficacy, and the limited efficacy of mood stabilisers in the depressive phase of the disorder, this is a major unmet need.
  
  
  METHODS
  This study reports data on the treatment of 149 individuals with moderate depression during the 2 month open label phase of a randomised placebo controlled clinical trial of the efficacy of 1g BID of NAC that examined the use of NAC as a maintenance treatment for bipolar disorder.
  
  
  RESULTS
  In this trial, the estimated mean baseline Bipolar Depression Rating Scale (BDRS) score was 19.7 (SE=0.8), and the mean BDRS score at the end of the 8 week open label treatment phase was 11.1 (SE=0.8). This reduction was statistically significant (p<0.001). Improvements in functioning and quality of life were similarly evident.
  
  
  CONCLUSIONS
  These open label data demonstrate a robust decrement in depression scores with NAC treatment. Large placebo controlled trials of acute bipolar depression are warranted.
authors: Department of Psychiatry, The University of Melbourne, Parkville, Australia. mikebe@barwonhealth.org.au
authors: Michael
authors: M
authors: Berk
authors: Olivia
authors: O
authors: Dean
authors: Sue M
authors: SM
authors: Cotton
authors: Clarissa S
authors: CS
authors: Gama
authors: Flavio
authors: F
authors: Kapczinski
authors: Brisa S
authors: BS
authors: Fernandes
authors: Kristy
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authors: Kohlmann
authors: Susan
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authors: Jeavons
authors: Karen
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authors: Hewitt
authors: Christine
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authors: Allwang
authors: Heidi
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authors: Cobb
authors: Ashley I
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authors: Bush
authors: Ian
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authors: Schapkaitz
authors: Seetal
authors: S
authors: Dodd
authors: Gin S
authors: GS
authors: Malhi
mesh_terms: D000111:Acetylcysteine / Q000008:administration & dosage*; D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D018692:Antimanic Agents / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D003863:Depression / Q000188:drug therapy; D003866:Depressive Disorder / Q000188:drug therapy; D005260:Female; D016166:Free Radical Scavengers / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000188:drug therapy; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D018692:Antimanic Agents; D016166:Free Radical Scavengers; D000111:Acetylcysteine