CompletedPhase 2Phase 3ACTRN12613000310763

N-Acetyl Cysteine for the Treatment of Obsessive Compulsive Disorder (OCD): A Double-Blind, Randomised, Placebo-Controlled Clinical Trial

N-Acetyl Cysteine for the Treatment of Obsessive Compulsive Disorder (OCD)


Sponsor

The Melbourne Clinic

Enrollment

80 participants

Start Date

Mar 13, 2013

Study Type

Interventional

Conditions

Summary

The primary aim of this study is to investigate the efficacy and safety of adjunctive N-acetylcysteine (NAC) in the treatment of adults (n=80) with DSM-IV diagnosed OCD in a 16-week randomised, placebo-controlled trial. The primary outcome will be between group differences the severity of OCD symptoms on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria5

  • Fulfil DSM-IV TR diagnostic criteria for OCD
  • Self reported OCD will require a diagnosis from a physician
  • Score 16+ on the Y-BOCS at the time of recruitment
  • No other treatment, or be on stable treatment i.e. minimum 4 weeks of treatment or minimum of 12 weeks if a new treatment (e.g. SSRI, CBT)
  • Female participants of child bearing age or sexually active are required to be using effective contraception

Exclusion Criteria7

  • Known or suspected serious medical disorder i.e. cancer, organ failure
  • Patients undergoing current psychological programs for their OCD (a four week wash out period will be required for eligibility)
  • Bipolar I, schizophrenia, epilepsy
  • Gastrointestinal ulcers
  • Pregnancy or breastfeeding
  • History of hypersensitivity or intolerance to NAC
  • Patients taking 100 micrograms of selenium or 500 IU of vitamin E

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Interventions

N-acetyl cysteine (NAC): 500mg capsules taken orally - 1 capsule twice daily for 1 week, 2 capsules twice daily for the second week and 3 capsules twice daily (3g/day) for the remaining 13 weeks (tota

N-acetyl cysteine (NAC): 500mg capsules taken orally - 1 capsule twice daily for 1 week, 2 capsules twice daily for the second week and 3 capsules twice daily (3g/day) for the remaining 13 weeks (total 16 weeks).


Locations(1)

The Melbourne Clinic - Richmond

VIC, Australia

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ACTRN12613000310763


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