Personalized Indications for CBT and Antidepressants in Treating Depression

Depression currently affects close to 2 million Canadians and is the leading cause of disability worldwide. Pharmacological treatments (antidepressant medication) and psychological treatments such as cognitive-behavioural therapy are available for depression, but the majority of those who receive treatment have an unsatisfactory response. On average, the combination of pharmacological and psychological treatment achieves better results than either treatment alone. However, the apparently superior results of combination treatment may be due to the fact that different individuals preferentially respond to pharmacological or psychological treatment. The invesitagtors have discovered several clinical factors and biomarkers that predict poor response to commonly used antidepressant medication: history of childhood maltreatment, loss of interest and reduced activity, a biomarker of systemic inflammation, and a genetic marker of sensitivity to environment. Indirect evidence suggests that the same factors may indicate the need for psychological treatment, but their usefulness as differential predictors of psychological and pharmacological treatment outcomes remains to be established. The investigators will test the hypothesis that a pre-determined clinical variables (history of childhood maltreatment, loss of interest and reduced activity) and biomarkers (serum C-reactive protein, a marker of systemic inflammation, and insulin resistence, an indicator of metabolic health) differentially predict response to antidepressants and to cognitive-behavioural psychotherapy with clinically significant accuracy. If this hypothesis is supported, the resulting predictor will allow personalized selection of treatment for depression, leading to improved outcomes and healthcare efficiency. Additional objectives include replication of additional predictors and integrative analyses aimed at refining the treatment choice algorithms.

NCT Number	NCT02752542
Lead Sponsor	Nova Scotia Health Authority Collaborators: University Health Network, Toronto, Queen's University, Centre for Addiction and Mental Health
Conditions	Major Depressive Disorder, Persistent Depressive Disorder
Enrollment	80 participants
Start Date	2016-10-31
Primary Completion	2026-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2025-05-14