None listed
Conditions
Brief summary
The study will assess the effects of a nutrient supplement (nutraceutical) combination in individuals with treatment-refractory obsessive-compulsive disorder. The study is a 5 month, open-label, multicentre pilot study.
Interventions
All enrolled participants will receive the following nutrient supplements for the 20 weeks of the study:
*Compounded N-acetylcysteine (NAC) and L-theanine (LT) capsules, 500mg and 100mg per capsule respectively. Two capsules taken twice per day (2,000mg NAC and 400mg LT per day). Dose will be titrated to three capsules, twice per day in cases of non-response from Week-8 in the study (non-response defined as < 35% reduction in Week-8 Y-BOCS score in comparison to baseline).
*Zinc liquid (25 dro
All enrolled participants will receive the following nutrient supplements for the 20 weeks of the study: *Compounded N-acetylcysteine (NAC) and L-theanine (LT) capsules, 500mg and 100mg per capsule respectively. Two capsules taken twice per day (2,000mg NAC and 400mg LT per day). Dose will be titrated to three capsules, twice per day in cases of non-response from Week-8 in the study (non-response defined as < 35% reduction in Week-8 Y-BOCS score in comparison to baseline). *Zinc liquid (25 drops per day, 28.4mg elemental zinc per day) *Selenium liquid (5 drops per day, 113mcg elemental selenium per day) *Magnesuim and Vitamin B6 tablets (1 tablet per day, 150 elemental magnesium, 50mg pyridoxal-5-phosphate). Participants will be asked to return their nutrient supplements at each follow-up visit where capsules/tablets will be counted, and liquid measured to determine compliance. New supplements will be dispensed at each visit as required.
Sponsors
Prof Jerome Sarris
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
*18-75 years of age *Y-BOCS score of equal to or greater than 16 at time of entry into the study *Treatment-Refractory OCD (defined as inadequate response to 1. at least 3 trials to serotonin-reuptake inhibitor medications; 2. an augmentation trial, for example, an antipsychotic medication; 3. at least 15 sessions of cognitive and/or behavioural therapy with an experienced clinician OR completion of one in-patient program specific for OCD treatment. *Stable treatment for the previous 4 weeks (for example, consistent doses of medications used for their OCD, regular appointments with psychologist for behavioural therapy) OR not currently employing treatment for their OCD
Exclusion criteria
*Diagnosis of bipolar disorder *Diagnosis of psychotic disorder *Strong suicidal ideation (defined as Hamilton Depression rating scale, item-3 score equal to or greater than 3) *Diagnosis of alcohol or substance abuse *Medications with known or suspected interactions with any of the investigated nutrients, to be determined by the medical investigators on a case by case basis *Allergy to any component of the investigational products *Serious or unstable medical conditions, to be determined by the medical investigators on a case by case basis *Gastrointestinal ulcers or renal stones within the last 2 years *Pregnancy of women currently breastfeeding
Outcome results
None listed