Mitochondrial agents in the treatment of bipolar disorder
- Conditions
- bipolar depressionMental Health - Other mental health disordersMental Health - Depression
- Registration Number
- ACTRN12612000830897
- Lead Sponsor
- Mental Health Research Institute- University of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 225
1. Must be required to meet DSM-IV criteria for bipolar disorder (I, II or NOS)
2. Have a current episode of depressive illness with a MADRS score greater than or equal to 20
3. Have capacity to consent to the study and comply with study procedures
4. Using effective contraception if female, sexually active and of child bearing potential
5. Any form of therapy must be stable for the last month.
1. Participants with known or suspected active systemic medical disorder
2.Recent gastrointestinal ulcers
3. Individuals who are pregnant or lactating
4. Individuals with a diagnosis of epilepsy
5. Individuals currently taking >250mg of n-acetylcysteine; >250mg of acetyl l-carnitine; or >25mg of coenzyme Q10
6. Individuals taking over 200ug of selenium/ day
7. Individual requiring warfarin or phenytoin
8. Participants currently enrolled in another intervention study
9. Participants who are intolerant to or have had an anaphylactic reaction to any components in the preparation.
10. Participants who are unable to comply with requirements of informed consent or treatment protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint for this trial is mean change in depressive symptoms of bipolar disorder measured using MADRS.[The MADRS will be conducted at all trial visits ( every 4 weeks) including the 16 weeks of treatment and at the post-discontinuation visit at week 20.]
- Secondary Outcome Measures
Name Time Method