The Treatment for Adolescents with Depression Study (TADS): methods and message at 12 weeks.

摘要: ABSTRACT Objective To compare the rates of physical, psychiatric, and suicide-related events in adolescents with MDD treated fluoxetine alone (FLX), cognitive-behavioral therapy (CBT), combination treatment (COMB), or placebo (PBO). Method Safety assessments included adverse (AEs) collected by spontaneous report, as well systematic measures for specific physical psychiatric symptoms. Suicidal ideation suicidal behavior were systematically assessed self- clinician reports. also reanalyzed Columbia Group expert raters using Columbia-Classification Algorithm Assessment used U.S. Food Drug Administration reclassification effort. Results Depressed reported high symptoms at baseline, which improved depression improved. Sedation, insomnia, vomiting, upper abdominal pain occurred least 2% those FLX and/or COMB twice rate placebo. The AEs was 11% FLX, 5.6% COMB, 4.5% PBO, 0.9% CBT. overall, greatest improvement COMB. Twenty-four during 12-week period: 5 patients (4.7%) 10 (9.2%) (4.5%) CBT, 3 (2.7%) Statistically, only had more than PBO ( p =.0402, odds ratio (OR) = 3.7, 95% CI 1.00-63.7). Only five actual attempts (2 2 1 0 PBO). There no suicide completions. Conclusions Different methods eliciting produce different results. In general, improves, complaints decrease proportion to benefit. this study, are common FLX-treated patients. may offer a favorable safety profile medication adolescent depression.