Actively Recruiting
Personalized Indications for CBT and Antidepressants in Treating Depression
Led by Nova Scotia Health Authority · Updated on 2025-05-14
80
Participants Needed
1
Research Sites
552 weeks
Total Duration
On this page
Sponsors
N
Nova Scotia Health Authority
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Indications for CBT and Antidepressants in Treating Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of major depressive disorder (MDD) or persistent depressive disorder (PDD) confirmed by structured clinical interview
- Depression is the main problem needing clinical attention
- Minimum severity score of 14 on the 17-item Hamilton Rating Scale for Depression
- Depression lasting at least two months
- Age 18 years or older
- Ability to give informed consent
You will not qualify if you...
- Lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, or schizoaffective disorder
- Current alcohol or drug use disorder
- Pregnancy
- Received 10 or more psychological treatment sessions in past 12 months
- Started new antidepressant medication in past 12 weeks or increased dose in past 6 weeks
- Previous non-response to two or more study medications
- Acute suicide risk (score 4 or higher on MADRS suicide item)
- Current psychotic symptoms
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2E2
Actively Recruiting
Research Team
R
Rudolf Uher, MD, PhD
CONTACT
J
Jill Cumby, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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