Personalized Indications for Cognitive Behavioural Therapy and Antidepressants in the Treatment of Major Depressive Disorder and Persistent Depressive Disorder

Who is this study for? Patients with Major Depressive Disorder
Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5), and depression being the primary problem requiring clinical attention (judgement of intake clinician).

• a minimum current severity of 14 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)

• a cumulative duration of depression of at least two months (this will exclude short-lasting first depressive episodes that do not require treatment of this intensity), age 18 or more (no upper limit)

• capacity to provide informed consent.

Locations
Other Locations
Canada
Nova Scotia Health Authority
RECRUITING
Halifax
Contact Information
Primary
Rudolf Uher, MD, PhD
rudolf.uher@nshealth.ca
1-902-473-7209
Backup
Jill Cumby, RN
jill.cumby@nshealth.ca
902-473-1782
Time Frame
Start Date: 2016-10-31
Estimated Completion Date: 2027-06
Participants
Target number of participants: 80
Treatments
Experimental: Psychotherapy
Cognitive Behavioral Therapy
Experimental: Pharmacotherapy
Antidepressant medication
Related Therapeutic Areas
Sponsors
Collaborators: Queen's University, Centre for Addiction and Mental Health, University Health Network, Toronto
Leads: Nova Scotia Health Authority

This content was sourced from clinicaltrials.gov