Daily process methodology for measuring earlier antidepressant response

Abstract

Objective Rapid onset of therapeutic action for antidepressant medication represents a major area of unmet medical need, and any such effects have been difficult to detect using standard study designs and measurement strategies. We conducted a randomized, open-label study with blinded raters using daily process assessment vs. standard weekly assessment to answer the following study questions: 1) is it possible to detect an antidepressant response more rapidly with daily assessment than with standard assessment approaches? 2) what is the burden of daily assessment on participants relative to standard clinical assessments? and 3) does the process of completing daily assessments have any effect on clinic-based assessments such as the Hamilton Depression Rating Scale (HAM-D)? Method Seventy-eight outpatients with major depressive disorder who received open-label fluoxetine were randomized to standard weekly clinic assessment or standard weekly clinic assessment plus daily assessment, and were followed for 28 days. Data were collected between September, 2002 and August, 2003. Results Daily assessment appeared to have no effect on 17-item HAM-D or MADRS scores obtained in the clinic. Survival analyses revealed that daily diaries detected therapeutic effects more quickly than did standard weekly clinic assessments, across most endpoints. Perceived burden of study participation was not significantly increased by daily diary completion, nor reflected in higher dropout rates. Conclusion Daily process assessment improves the ability to detect an early antidepressant response.