None listed
Conditions
Brief 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).
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 (total 16 weeks).
Sponsors
The Melbourne Clinic
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 65 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed