PURPOSE: The aim of this study was to assess the efficacy and safety of sertraline compared with placebo in a good clinical practice trial conducted with major depressive disorder patients naive to selective serotonin reuptake inhibitors. METHODS: This was a 10-week randomized, multicenter, placebo-controlled, double blind, superiority trial. Adult patients diagnosed with major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria), total score of 19 to 36 in the 17-item Hamilton Depression Rating Scale (HAMD-17), were randomly allocated to sertraline (n = 39) or placebo (n = 38). Each patient received a fixed dose of sertraline 50 mg/d or placebo for 4 weeks. Afterward a flexible dose up to 200 mg/d was allowed if needed. The primary efficacy end point was clinical response defined as 50% score reduction in HAMD-17 at 10 weeks relative to baseline. Supplementary analysis was performed on HAMD-17 score change from baseline. FINDINGS: The clinical response favored sertraline (72% vs 32%; relative risk, 2.27; 95% confidence interval, 1.37-3.78; P = 0.0006). A linear mixed model showed arm × time interaction was significant (likelihood ratio test χ on 7 df = 48.42, P < 0.0001). The HAMD-17 change score favored sertraline from week 8 onwards. The most frequent adverse events in the sertraline arm were headache, diarrheas, and weight loss. IMPLICATIONS: In this trial, the benefit of sertraline compared with placebo appeared later than usual. The therapeutic process with a close doctor-patient relationship throughout the trial and the effect expectancy due to a new treatment might explain the response delay. TRIAL REGISTRATION: RPCEC, ID no. 00000128.
RCT Entities:
PURPOSE: The aim of this study was to assess the efficacy and safety of sertraline compared with placebo in a good clinical practice trial conducted with major depressive disorderpatients naive to selective serotonin reuptake inhibitors. METHODS: This was a 10-week randomized, multicenter, placebo-controlled, double blind, superiority trial. Adult patients diagnosed with major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria), total score of 19 to 36 in the 17-item Hamilton Depression Rating Scale (HAMD-17), were randomly allocated to sertraline (n = 39) or placebo (n = 38). Each patient received a fixed dose of sertraline 50 mg/d or placebo for 4 weeks. Afterward a flexible dose up to 200 mg/d was allowed if needed. The primary efficacy end point was clinical response defined as 50% score reduction in HAMD-17 at 10 weeks relative to baseline. Supplementary analysis was performed on HAMD-17 score change from baseline. FINDINGS: The clinical response favored sertraline (72% vs 32%; relative risk, 2.27; 95% confidence interval, 1.37-3.78; P = 0.0006). A linear mixed model showed arm × time interaction was significant (likelihood ratio test χ on 7 df = 48.42, P < 0.0001). The HAMD-17 change score favored sertraline from week 8 onwards. The most frequent adverse events in the sertraline arm were headache, diarrheas, and weight loss. IMPLICATIONS: In this trial, the benefit of sertraline compared with placebo appeared later than usual. The therapeutic process with a close doctor-patient relationship throughout the trial and the effect expectancy due to a new treatment might explain the response delay. TRIAL REGISTRATION: RPCEC, ID no. 00000128.