Antioxidants in bipolar disorder: A double blind randomised placebo controlled trial of n-acetyl cysteine.
Phase 3
Completed
- Conditions
- Bipolar disorderMental Health - Other mental health disordersNeurological - Other neurological disorders
- Registration Number
- ACTRN12605000362695
- Lead Sponsor
- Research Funds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
DSM-IV diagnosis of bipolar disorder (I, II or NOS), have had at least one mood episode within the last 12 months, have been on stable treatment for one month, have the capacity to consent and be on effective contraception.
Exclusion Criteria
Asthma, history of ulcers, respiritory insufficiency, any current systemic medical disorder, participants who are currently taking either 500mg of NAC/day, 200ug of selenium/day or 500 IU of Vitamin E/day and women pregnant or lactacting.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to intervention for mood episode[When occurred]
- Secondary Outcome Measures
Name Time Method YMRS[At each trial visit. (Total of nine visits).];BDRS[At each trial visit. (Total of nine visits).];Q-LES-Q[At each trial visit. (Total of nine visits).];Slice/life[At each trial visit. (Total of nine visits).];Life/rift[At each trial visit. (Total of nine visits).];SOFAS[At each trial visit. (Total of nine visits).];CGI [At each trial visit. (Total of nine visits).];GAF[At each trial visit. (Total of nine visits).]