A double-blind placebo-controlled trial of @entity2812 as an antidepressant augmentation agent in treatment-refractory XXXX .

@entity1 @entity308 @entity903 @entity3831 @entity13217 @entity2812
BACKGROUND: Previous reports have suggested that @entity2812 is effective as an antidepressant augmentation agent in @entity1 with treatment-resistant @entity308 . This study is the largest double-blind placebo-controlled study conducted to date of @entity2812 in this role. METHOD: In this multicenter trial, conducted at 19 sites, @entity1 aged 18-65 years with a DSM-IV/ICD-10 diagnosis of unipolar, nonpsychotic major @entity308 (confirmed by the Mini-International Neuropsychiatric Interview) who had failed at least 1 adequate trial of an antidepressant (N = 183) were first treated for 8 weeks with open-label @entity903 or @entity903 controlled-release in dosages up to 50 mg/d or 62.5 mg/d, respectively. Individuals with a 17-item Hamilton Depression Rating Scale ( @entity3831 -17) score >=  15 (n = 96) were then randomized on a double-blind basis to receive either placebo or @entity2812 in dosages titrated upward to a maximum of 400 mg/d for 10 weeks. Sixty-five @entity1 completed the study. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS), and the main secondary outcome measures were the @entity3831 -17 and Clinical Global Impressions-Severity of Illness (CGI-S) and Clinical Global Impressions-Improvement (CGI-I) ratings. Data were collected from 2003 to 2006. RESULTS: Results of the primary efficacy analysis of the randomized @entity1 using the MADRS, @entity3831 -17, CGI-S, and CGI-I did not demonstrate a statistically significant difference between @entity2812 and placebo groups, although some secondary analyses were suggestive of efficacy, particularly in those @entity1 who completed the study (completer analysis) and in more severely ill @entity1 ( @entity3831 -17 >=  25). CONCLUSIONS: This add-on study of @entity1 with @entity13217 failed to detect a statistically significant difference between @entity2812 and placebo given for 10 weeks. However, post hoc analyses suggest that future studies of @entity2812 's efficacy might focus on specific subgroups with @entity308 . TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00901407.
