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Antidepressant
CBT + Antidepressants for Depression (CANBIND6 Trial)
Phase 4
Recruiting
Led By Rudolf Uher, MD, PhD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
recent receipt of adequate trial of psychological treatment (10 or more sessions in the past 12 months)
previous non-response to two or more of study medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-52 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trialwill test if certain clinical factors & biomarkers predict better response to antidepressant medication or cognitive-behavioural therapy for depression, allowing for personalized treatment & improved outcomes.
Who is the study for?
This trial is for adults over 18 with depression lasting at least two months, diagnosed with Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD), and a Hamilton Rating Scale for Depression score of 14+. They must see depression as their main issue and can consent. Excluded are those with psychosis, pregnancy, bipolar/schizophrenia spectrum disorders, recent substance abuse disorder, extensive recent CBT or non-response to study meds.
What is being tested?
The trial tests if certain clinical factors and biomarkers predict better outcomes in treating depression with Cognitive Behavioral Therapy versus antidepressants. It aims to personalize treatment by identifying who responds best to which therapy based on childhood maltreatment history, activity levels, inflammation markers (C-reactive protein), and genetic markers.
What are the potential side effects?
While not specified here, common side effects of antidepressants include nausea, weight gain, fatigue, insomnia; whereas Cognitive Behavioral Therapy generally has no direct physical side effects but may initially increase emotional distress due to confronting difficult issues.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have completed 10 or more therapy sessions in the last year.
Select...
I have not responded to at least two study medications before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total score on the Montgomery Asberg Depression Rating Scale (MADRS)
Secondary study objectives
Global-Clinical Impression scale (GCI)
Quick Inventory of Depressive Symptoms (QIDS-SR)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: PsychotherapyExperimental Treatment1 Intervention
Cognitive Behavioral Therapy
Group II: PharmacotherapyExperimental Treatment1 Intervention
Antidepressant medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3120
Pharmacotherapy
2003
Completed Phase 4
~1590
Find a Location
Who is running the clinical trial?
University Health Network, TorontoOTHER
1,531 Previous Clinical Trials
503,962 Total Patients Enrolled
Centre for Addiction and Mental HealthOTHER
375 Previous Clinical Trials
82,527 Total Patients Enrolled
Queen's UniversityOTHER
375 Previous Clinical Trials
121,393 Total Patients Enrolled
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,202 Total Patients Enrolled
Rudolf Uher, MD, PhDPrincipal InvestigatorNova Scotia Health Authority
4 Previous Clinical Trials
30,524 Total Patients Enrolled