XXXX in practice-based clinical settings: assessing effects on the emotional and physical symptoms of @entity308 in an open-label, multicenter study.

@entity1 @entity308 @entity4480 @entity146
OBJECTIVE: In placebo-controlled clinical trials, @entity4480 has been shown to be effective and well-tolerated in @entity1 with @entity308 ( @entity308 ). However, @entity1 in registration trials may not be representative of @entity1 in clinical practice. This study sought to assess the effectiveness, safety, and tolerability of @entity4480 in diverse populations of outpatients with @entity308 . METHOD: This open-label study recruited out- @entity1 >=  18 years of age with DSM-IV @entity308 in primary care or @entity146 practice settings and treated them with @entity4480 60 mg q.d. for 7 weeks. Primary outcome measures were (1) the physicianrated Clinical Global Impressions-Severity of Illness scale, (2) the @entity1 -rated 28-item Somatic Symptom Inventory (SSI-28) average, and (3) the @entity1 -rated 16-item Quick Inventory of Depressive Symptomatology-Self Report. Quality of life, disability, and vital signs also were assessed. The first @entity1 visit was August 16, 2004. The last @entity1 visit was January 7, 2005. RESULTS: Of 3543 outpatients enrolled, 3431 received at least 1 dose of @entity4480 , of whom 71.4% completed the study. Most @entity1 were Caucasian (90.8%) and female (75.4%); mean age was 48 years. @entity4480 significantly (p < .001) improved all efficacy measures in all treated @entity1 as well as in subgroups based on gender, ethnic origin, age, and @entity1 care setting. Except for the SSI-28 average, all the efficacy measures were in favor of female gender and primary care subgroups. Overall, 10.8% of @entity1 discontinued due to adverse events. CONCLUSION: @entity4480 60 mg q.d. was effective, regardless of gender, ethnic origin, age, and @entity1 care settings, in this 7-week open-label study and was well-tolerated in a diverse population of outpatients with @entity308 . CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00479726.
