Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of XXXX : A randomized, double-blind, parallel-group, prospective study.

@entity162 @entity308 @entity2749 @entity906 @entity1091
OBJECTIVE: Compare the safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for preventing @entity308 in @entity162 . METHODS: Subjects >= 18 years old with @entity162 (n=129) were randomized to double-blind @entity906 or @entity1091 monotherapy for 12 weeks. Responders with a >= 50% reduction in @entity308 score were continued for an additional 6 months of relapse-prevention monotherapy. Primary outcome was @entity308 during continuation monotherapy. Secondary outcomes included sustained response rate from initiation of treatment to study end-point, relapse hazard, time to relapse, change in @entity162 ratings, and frequency of treatment-emergent sub-syndromal hypomania and/or @entity308 episodes. RESULTS: @entity906 produced greater sustained response rate versus @entity1091 (p<0.0001); however, there was no difference in relapse rate for @entity906 (7.5%) versus @entity1091 (26.7%) (p=0.079); relapse hazard (p=0.073), or time to relapse (p=0.090) between treatment conditions during continuation monotherapy. There were no group differences in @entity162 rating scores over time and no difference in frequency or duration of @entity2749 . There were more sub-syndromal @entity308 episodes during @entity1091 monotherapy (p=0.03). LIMITATIONS: Sample size was limited by the lower sustained response rate for @entity1091 versus @entity906 ; study was not specifically powered to detect differences in treatment-emergent hypomanic or @entity308 episodes between groups. CONCLUSION: Results suggest that continuation @entity906 monotherapy may provide similar prophylactic effectiveness relative to @entity1091 , with no difference in treatment-emergent hypomanic episodes and without the need for frequent serum @entity1091 level and metabolic monitoring. Larger, prospective trials are needed to confirm these observations.
