N-acetyl cysteine (NAC) augmentation in Obsessive-Compulsive Disorder (OCD): A 24-week, randomized, double blind placebo controlled trial

Funding

Government body,The National Heath and Medical Research Council

Scientific enquiries

Miss Georgina Oliver

Brief Summary

This study seeks to elucidate the benefits of NAC augmentation (2-4 grams/day) compared to placebo in the treatment of OCD, in a 24-week, multi-centre, randomized, double-blind, placebo controlled trial. It is hypothesized that NAC will be superior over placebo for improving OCD symptoms as measured by a reduction in Y-BOCS scores from baseline against each subsequent time point (W4, W8, W12, W16, W20 and W24). Additional benefits are anticipated for relieving anxiety as well as improving mood, .... This study seeks to elucidate the benefits of NAC augmentation (2-4 grams/day) compared to placebo in the treatment of OCD, in a 24-week, multi-centre, randomized, double-blind, placebo controlled trial. It is hypothesized that NAC will be superior over placebo for improving OCD symptoms as measured by a reduction in Y-BOCS scores from baseline against each subsequent time point (W4, W8, W12, W16, W20 and W24). Additional benefits are anticipated for relieving anxiety as well as improving mood, functioning and overall quality of life.
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Key Inclusion Criteria

Primary diagnosis of OCD as per the Structured Interview Guide for the DSM-5 (SCID) Adults between the age of 18-75 who have the desire and capacity to consent to the study and follow its procedures. Minimum score of 16 on the Y-BOCS at time of entry into the study, but no greater than 31. Currently taking medication for their OCD which has been at a stable dose for the past 8-weeks. Stable psychological treatment (if employing) for minimum eight weeks (an 8-week wash-out period will be required .... Primary diagnosis of OCD as per the Structured Interview Guide for the DSM-5 (SCID) Adults between the age of 18-75 who have the desire and capacity to consent to the study and follow its procedures. Minimum score of 16 on the Y-BOCS at time of entry into the study, but no greater than 31. Currently taking medication for their OCD which has been at a stable dose for the past 8-weeks. Stable psychological treatment (if employing) for minimum eight weeks (an 8-week wash-out period will be required if participants have just completed an intensive in-patient CBT program for their OCD).
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Key Exclusion Criteria

*Bipolar disorder *Psychotic disorders *Primary diagnosis of Obsessive-compulsive spectrum disorders including hoarding, body dysmorphic disorder, trichotillomania (secondary diagnosis permitted) *Severe depression (as defined by HAM-D score equal to or greater than 24 *Alcohol/substance abuse *Y-BOCS score equal to or greater than 32 *Treatment resistant OCD (3 or more trials of first line medications for their OCD at therapeutic doses for minimum of 12-weeks each, at least one augmentation str .... *Bipolar disorder *Psychotic disorders *Primary diagnosis of Obsessive-compulsive spectrum disorders including hoarding, body dysmorphic disorder, trichotillomania (secondary diagnosis permitted) *Severe depression (as defined by HAM-D score equal to or greater than 24 *Alcohol/substance abuse *Y-BOCS score equal to or greater than 32 *Treatment resistant OCD (3 or more trials of first line medications for their OCD at therapeutic doses for minimum of 12-weeks each, at least one augmentation strategy, for example, anti psychotic medication as well as exposure response prevention therapy minimum 20 hours) *Medications with known or suspected negative interactions with NAC (activated charcoal, nitro glycerine, insulin replacement therapies, Aralen, anti-coagulant medications excluding aspirin and NSAIDS)
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