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. 2021 Oct 8;2021(10):CD011611. doi: 10.1002/14651858.CD011611.pub3

ACTRN12612000830897.

Study name Mitochondrial agents in the treatment of bipolar disorder
Methods Three‐arm, parallel randomised controlled trial
Participants DSM‐IV bipolar disorder, current depressive phase (MADRS < 19), stable other therapy, 18+
Interventions 1. N‐acetylcysteine (NAC) capsules for 16 weeks (500 mg twice a day)
2. Acetyl L carnitine 500 mg + mitochondrial combination capsule + cardonutrient capsule for 16 weeks
3. Placebo treatment for 16 weeks
Outcomes BL and every 4 weeks afterwards (6 visits)
MADRS
BDRS
HAM‐A
YMRS
Impairment Functioning Tool
SOFAS
QLES‐Q
CGI BP and CGI‐I
Patient global impressions scale
Change in blood oxidative and inflammatory markers
Starting date 4/3/2013
Contact information Professor Michael Berk
Mental Health Swanston Centre PO BOX 281 GEELONG VIC 3220
mikebe@barwonhealth.org.au
Notes Recruiting