Actively Recruiting
Personalized Indications for Cognitive Behavioural Therapy and Antidepressants in the Treatment of Major Depressive Disorder and Persistent Depressive Disorder
Led by Nova Scotia Health Authority · Updated on 2025-05-14
80
Participants Needed
1
Research Sites
52 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 is a common and disabling condition affecting millions worldwide, including nearly 2 million Canadians. This research aims to improve treatment by studying how specific clinical factors and biomarkers can predict whether an individual will respond better to antidepressant medication or cognitive-behavioral therapy (CBT). The study focuses on adults diagnosed with major depressive disorder or persistent depressive disorder, exploring personalized treatment choices to enhance outcomes and healthcare efficiency. Participants will be randomly assigned to receive either CBT or antidepressant medication. CBT involves up to 20 one-on-one sessions over 18 weeks, starting twice weekly and gradually spacing out, delivered by trained therapists following a structured protocol. Pharmacotherapy includes psychiatrist-prescribed antidepressants, mainly serotonin-reuptake inhibitors like escitalopram or sertraline, with possible augmentation if needed. Medication sessions occur every two weeks and follow established clinical guidelines. During the study, participants will undergo regular assessments using depression rating scales such as the Montgomery Asberg Depression Rating Scale over 2 to 52 weeks. Researchers will monitor symptom changes, treatment response, and safety throughout. The study will also collect data on clinical predictors and biomarkers to evaluate their ability to guide personalized treatment selection. Total participation lasts up to one year, with ongoing evaluations to refine treatment algorithms and improve care for depression.
CONDITIONS
Brief 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 a structured clinical interview
- Depression is the main problem requiring clinical attention
- Minimum severity score of 14 on the 17-item Hamilton Rating Scale for Depression
- Depression lasting at least 2 months
- Age 18 years or older
- Ability to provide 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 psychotherapy sessions in the past 12 months
- Started new antidepressant medication in the 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks
Participants receive either cognitive behavioral therapy or antidepressant medication to treat depression. CBT includes up to 20 sessions over 18 weeks with initially twice-weekly sessions, then weekly, then every other week. Pharmacotherapy involves medication management with psychiatrist visits every two weeks.
Up to 20 therapy sessions and biweekly medication visits as applicable
Duration - Up to 34 weeks after treatment
Participants are monitored for treatment outcomes and symptom changes after the treatment period ends, including assessments of depression severity.
Regular assessment visits up to Week 52
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
J
Jill Cumby, RN
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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