Efficacy of early administration of @entity837 on XXXX and @entity51 after @entity64 : a multicentre, double-blind, randomised, placebo-controlled study.

@entity1 @entity64 @entity308 @entity294 @entity1316 @entity837 @entity51 @entity925 @entity1142 @entity22
BACKGROUND: @entity1316 are common in @entity1 with @entity64 , and adversely affect the clinical outcome. We aimed to evaluate the efficacy of early administration of @entity837 to reduce moderate or severe @entity308 and improve emotional and @entity51 in @entity1 with @entity64 . METHODS: This was a placebo controlled, double-blind trial done at 17 centres in South Korea. @entity1 who had had an @entity64 within the past 21 days were randomly assigned in a 1:1 ratio to receive oral @entity837 (10 mg/day) or placebo for 3 months. Randomisation was done with permuted blocks stratified by centre, via a web-based system. The primary endpoint was the frequency of moderate or severe @entity308 (Montgomery-  sberg Depression Rating Scale [MADRS] >= 16). Endpoints were assessed at 3 months after randomisation in the full analysis set ( @entity1 who took study medication and underwent assessment of primary endpoint after randomisation), in all @entity1 who were enrolled and randomly assigned (intention to treat), and in all @entity1 who completed the trial (per-protocol analysis). This trial is registered with ClinicalTrials.gov, number NCT01278498. FINDINGS: Between Jan 27, 2011, and June 30, 2014, 478 @entity1 were assigned to placebo (n=237) or @entity837 (n=241); 405 were included in the full analysis set (195 in the placebo group, 210 in the @entity837 group). The primary outcome did not differ by study group in the full analysis set (25 [13%] @entity1 in the placebo group vs 27 [13%] in the @entity837 group; odds ratio [OR] 1  00, 95% CI 0  56-1  80; p>0  99) or in the intention-to-treat analysis (34 [14%] vs 35 [15%]; OR 1  01, 95% CI 0  61-1  69, p=0  96). The study medication was generally well tolerated; the most common adverse events were @entity1142 (14 [6%] @entity1 who received placebo vs 14 [6%] who received @entity837 ), @entity925 (16 [7%] vs ten [4%]), and @entity22 (12 [5%] vs 12 [5%]). @entity294 was more common in the @entity837 group (nine [4%] @entity1 ) than in the placebo group (two [1%] @entity1 ). INTERPRETATION: @entity837 did not significantly reduce moderate or severe @entity308 in @entity1 with @entity64 . FUNDING: Dong-A Pharmaceutical and Ministry for Health, Welfare, and Family Affairs, South Korea.
