Background: Functional recovery is increasingly recognized as a priority in the treatment of major depressive disorder (MDD), by both clinicians and patients. However, symptom improvement remains the focus of traditional clinical trials for MDD and of the regulatory approval process for new medications and other interventions. Many studies have shown that functional outcomes do not always correspond to symptom-based outcomes.
Methods: Representatives from clinical practice, professional societies, academia, industry, and government were invited by the Canadian Network for Mood and Anxiety Treatments to develop recommendations for the conceptualization and measurement of functional outcomes in clinical trials of MDD.
Results: Definitions and conceptual frameworks to guide assessment of functioning are described, as well as research methodology applicable to the broad spectrum of treatments for MDD. Examples are given for validated instruments, including patient-reported outcome measures. Strategies for knowledge translation and dissemination are suggested and consensus recommendations summarized.
Conclusions: As the societal burden and financial costs of MDD continue to escalate, so does the need for evidence-based and cost-effective interventions that demonstrate improvement in functioning. Routine assessment of functional outcomes will benefit not only individuals with MDD but also diverse stakeholders concerned about the efficacy and cost-effectiveness of interventions.