Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT02752542

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada, B3H 2E2

Actively Recruiting

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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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