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Table 1 Inclusion and Exclusion Criteria

From: 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

Inclusion criteria

Exclusion criteria

Age ≥ 18 and able to provide written informed consent

Already taking NAC, selenium or vitamin E

History of anaphylactic reaction to NAC

Current PTSD

Meets criteria for DSM-5 diagnosis of PTSD according to CAPS-5 monthly version

Known or suspected clinically unstable systemic medical disorder

History of epilepsy

Current asthma

Recent gastrointestinal ulcers

Treatment resistant PTSD defined as

(a) Minimum 1x trial of an antidepressant (SSRI or SNRI) for minimum 6 weeks without adequate response OR (b) completed a course of trauma-focused psychotherapy

Currently pregnant or breastfeeding

Planning to conceive a child during the trial or 3 months following

If currently taking an antidepressant medication

• Minimum of 6-weeks if recently initiated

• Dose must be stable for minimum 2 weeks

History of psychotic illness

  1. NAC N-acetyl cysteine, PTSD Posttraumatic Stress Disorder, DSM-5 Diagnostic & Statistical Manual of Mental Disorders Fifth edition, CAPS-5 Clinician-Administered PTSD Scale for DSM-5, SSRI Selective-serotonin reuptake inhibitor, SNRI Serotonin and norepinephrine reuptake inhibitor