A randomized trial of a specific adherence enhancement program in sertraline-treated adults with major depressive disorder in a primary care setting.

Adherence to drug therapy is a limitation in treatment success for major depressive disorder (MDD). The influence of RHYTHMS, an information and ongoing interactive program designed by Pfizer Pharmaceuticals, to address patient adherence to sertraline therapy was evaluated in a primary care setting using a randomized, double-blind, parallel group controlled trial over 29 weeks. Remission was the primary outcome evaluated. At study completion, no statistically significance between group differences was noted for remission rates, treatment adherence or mean Hamilton Depression Rating Scale (HDRS) score. However, the RHYTHMS group reported significantly greater satisfaction with knowledge received about depression and its treatment and demonstrated significantly greater satisfaction with treatment received. We conclude that the application of RHYTHMS in a primary care setting has a substantial role in improving satisfaction with sertraline treatment by patients with MDD.

Sertraline and fluoxetine treatment of obsessive-compulsive disorder: results of a double-blind, 6-month treatment study.

The purpose of this study was to evaluate the comparative efficacy and tolerability of sertraline and fluoxetine in the treatment of obsessive-compulsive disorder (OCD). Outpatients meeting DSM-IV criteria for OCD, with a Yale-Brown Obsessive-Compulsive (Y-BOCS) total score >or= 17, an NIMH Global Obsessive-Compulsive (NIMH-OC) scale score >or= 7, and a CGI-Severity score >or= 4 were randomized to 24 weeks of double-blind treatment with sertraline (N = 77) or fluoxetine (N = 73). Primary efficacy measures consisted of the Y-BOCS, the NIMH-OC scale, and the CGI-Severity (CGI-S) and Improvement (CGI-I) scales. Equivalent and significant (p < 0.001) improvement was found at week 24 in Y-BOCS and NIMH-OC scale scores for sertraline and fluoxetine. After 12 weeks, 49.2% of patients on sertraline were rated on the CGI-S scale as being mildly ill or not ill compared to 24.6% on fluoxetine (p < 0.01). A Cox analysis found patients on sertraline to have a statistically nonsignificant 42% greater likelihood of achieving a response by week 12 (CGI-I, much or very much improved; 95% CI, 0.85, 2.38; p = 0.18). Sertraline treatment also resulted in a higher proportion of remissions than fluoxetine (defined as a CGI-I