Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/24514
Title: A multi-centre, double-blind, 12-week, randomized, placebo-controlled trial to assess the efficacy of adjunctive N-Acetylcysteine for treatment-resistant PTSD: a study protocol.
Austin Authors: Maier, Alice ;Dharan, Anita ;Oliver, Gina;Berk, Michael;Redston, Suzy ;Back, Sudie E;Kalivas, Peter;Ng, Chee;Kanaan, Richard A A 
Affiliation: Psychiatry (University of Melbourne)
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina; Ralph H. Johnson VA Medical Center, Charleston, SC, USA
Ralph H Johnson VA Medical Center, Charleston, SC, USA
Department of Neuroscience, Medical University of South Carolina, Charleston, USA
Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, Florey Institute for Neuroscience and Mental Health and the Department of Psychiatry, The University of Melbourne, Melbourne, Australia
IMPACT - the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Barwon Health, Geelong, Australia
Austin Health
Department of Psychiatry, The Melbourne Clinic, University of Melbourne, Richmond, VIC, Australia
Issue Date: 6-Aug-2020
Date: 2020-08-06
Publication information: BMC Psychiatry 2020; 20(1): 397
Abstract: Most patients with Posttraumatic Stress Disorder (PTSD) suffer residual symptoms following first-line treatment. Oxidative stress has been implicated in the pathophysiology of PTSD. N-acetylcysteine (NAC) is a precursor of the brain's primary antioxidant, glutathione, and may diminish oxidative cellular damage. An 8-week pilot study of NAC in veterans with PTSD found that symptoms were significantly reduced in the NAC group compared to placebo. This study aims to confirm these findings with a larger sample in a double-blind, placebo-controlled trial to further explore the efficacy of NAC as an adjunctive therapy in treatment-resistant PTSD. A multicentre, randomised, double-blind, placebo-controlled trial for adult patients who still meet criteria for PTSD following first-line treatment. The intervention comprises either NAC as a fixed dose regime of 2.7 g/day (900 mg three times daily) administered orally for 12 weeks, or placebo. Standard care for PTSD will continue in addition, including other pharmacotherapies. Detailed clinical data will be collected at randomisation and weeks 4, 8, 12, 16, and 64 post-randomisation, with self-report measures completed weekly from baseline to 16 weeks and at 64 weeks post-randomisation. Blood-based biomarkers will be collected at baseline and 12 weeks to assess the mechanism of effect. The primary outcome measure will be change in Clinician-Administered PTSD Scale for DSM-5 at 12 weeks compared with baseline. Secondary outcomes will be change in quality of life, depression, anxiety, substance use and craving, and somatic symptoms. With 126 completed participants (63 per arm), the study is powered at 80% to detect a true difference in the primary outcome measure using a two-tailed analysis with alpha = 0.05, beta = 0.2. This is the first multicentre, double blind, randomised, placebo-controlled trial of adjunctive NAC for treatment-resistant PTSD. NAC has an established safety profile, is readily available and easy to administer, and has a favourable tolerability profile, therefore making it an attractive adjunctive therapy. Inclusion of blood analyses to assess potential target engagement biomarkers of oxidative stress and neuroinflammation may help gauge the biological mechanisms of effect of NAC. ACTRN12618001784202, retrospectively registered 31/10/2018, URL: http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376004 .
URI: https://ahro.austin.org.au/austinjspui/handle/1/24514
DOI: 10.1186/s12888-020-02793-9
ORCID: 0000-0003-0992-1917
Journal: BMC Psychiatry
PubMed URL: 32762663
Type: Journal Article
Subjects: Adjunctive therapy
Biomarker
Clinical trial protocol
N-acetyl cysteine
Oxidative stress
Post-traumatic stress disorder
Randomised clinical trial
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