None listed
Conditions
Brief summary
Post Traumatic Stress Disorder (PTSD) is hard to treat effectively, as most patients who take the standard treatments still have PTSD symptoms afterwards. We have found that a drug called n-acetylcysteine (NAC), which supports the body’s anti-oxidants, can help to treat PTSD, as well as the depression and addictions that many people with PTSD also have. We would like to investigate this by doing a trial comparing NAC with placebo, in patients with PTSD who have already had the standard treatments, to see if NAC helps reduce PTSD symptoms. We will ask 192 individuals with PTSD from the general community, the Heidelberg Repatriation Hospital, and the Melbourne Clinic to join the study. These individuals would have tried standard treatments, but still be experience PTSD symptoms.. We will randomly divide them into two groups – one group which is given the NAC for 12 weeks, and one group which is given a placebo pill – though neither the researchers, nor the patients, will know which is which until the trial ends. They will keep taking their other treatments as usual. Every four weeks we will measure their PTSD symptoms, as well as their mood, their drug and alcohol use, somatic symptoms and their quality of life, until four weeks after the trial is over, when we will open the list that tells us who was taking the NAC, and who was taking the placebo, and compare the two groups. We expect that those who took the NAC will have fewer PTSD symptoms, better mood, less drug and alcohol use, fewer somatic symptoms and a better quality of life, and, most importantly, that more patients who took the NAC will no longer have PTSD.
Interventions
A 12-week, double blind, randomised, placebo-controlled trial of N-acetylcysteine, given as an adjunct therapy to those who still have PTSD despite having received first-line treatment.
This research is conducted by the Department of Psychiatry at the University of Melbourne in partnership with Austin Health and The Melbourne Clinic.
We aim to have 126 participants (63 per arm) complete the study. Participants will comprise individuals with PTSD. Participants will be recruited from the Psych
A 12-week, double blind, randomised, placebo-controlled trial of N-acetylcysteine, given as an adjunct therapy to those who still have PTSD despite having received first-line treatment. This research is conducted by the Department of Psychiatry at the University of Melbourne in partnership with Austin Health and The Melbourne Clinic. We aim to have 126 participants (63 per arm) complete the study. Participants will comprise individuals with PTSD. Participants will be recruited from the Psychological Trauma Recovery Service (PTRS) at the Heidelberg Repatriation Hospital, the Melbourne Clinic and from the community. Individuals accepted into the trial will be randomly allocated in a double-blind fashion to receive either NAC or placebo, in addition to any established treatments for their PTSD, by the trial pharmacy at the Heidelberg Repatriation Hospital. Random block allocation of packs will be in a four-to-a-block design, randomly generated by a computer program. A fixed dose regime of 2.7g/day of NAC, administered orally as 900mg, three times daily, will be used. To facilitate the double-blinding process, the trial medications (both NAC and placebo) will be dispensed in identical numbers and tablet forms in sealed containers, and the placebo containers will be specially treated with microgram levels of NAC dust to produce its characteristic smell (as manufactured in our previous study). Placebos will be manufactured according to EMA guidelines. The trial medications will be supplied on a monthly basis, and participants instructed to return all containers to allow capsule counts by the trial monitor and the trial pharmacist. Participants will also be required to complete a daily pill diary to document treatment compliance. Detailed clinical and demographic information will be collected on all participants at baseline. Participants will then be assessed at monthly clinical interviews throughout the 12-week trial, and at a post-discontinuation follow-up 16 weeks and 64 weeks post-randomisation, after completion of the trial (to assess retention of any treatment effects). Participants will be given the option to undertake blood analysis at baseline and at week 12 of the trial, to measure biomarkers associated with PTSD symptoms. Over the course of the trial, and for four weeks post-discontinuation, participants will complete a weekly questionnaire measure at home, assessing their PTSD symptoms. The baseline assessment will take about 90 minutes; the 4-weekly questionnaires take about 60 minutes to complete; the weekly self-report questionnaires take no more than 5 minutes. Information on potential adverse side effects will be collected systematically at 4, 8, 12 and 16 weeks post randomisation by the research clinicians, and will be managed according to medical assessment.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be considered for inclusion in this study, participants are required to be aged 18 or over; have the capacity to consent to the study and to follow its instructions and procedures; fulfil the DSM-5 diagnostic criteria for current PTSD (identified with the CAPS-5 monthly version); have completed a course of either trauma-focussed psychotherapy or an antidepressant; and if currently treated with an antidepressant the dose must have been stable for at least 2 weeks.
Exclusion criteria
Participants are ineligible to enter the trial if they have a psychotic illness; known or suspected clinically unstable systemic medical disorder; epilepsy, recent gastrointestinal ulcers; currently use N-acetylcysteine, selenium or Vitamin E; a history of anaphylactic reaction to N-acetylcysteine . Female patients cannot be pregnant or lactating, and all participants must agree to using adequate contraception during the trial.
Outcome results
None listed