Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomised placebo controlled trial Full Text
BMC Medicine, 08/17/2012
Berk M et al. – There were no significant between–group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations.Methods
- The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined.
- Participants (n = 149) had a Montgomery Asberg Depression Rating Score of [greater than or equal to]12 at trial entry and, after eight weeks of open–label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual.
- Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements.
- Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes.
- There was a substantial decrease in symptoms during the eight–week open–label NAC treatment phase.
- During the subsequent double–blind phase, there was minimal further change in outcome measures with scores remaining low.
- Consequently, from this low plateau, between–group differences did not emerge on recurrence, clinical functioning or quality of life measures.