Actively Recruiting

Phase 2
Age: 12Years - 25Years
All Genders
NCT05002309

Treatment Interrupts Depression Early

Led by Nova Scotia Health Authority · Updated on 2025-05-14

100

Participants Needed

2

Research Sites

369 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The TIDE project aims to establish personal indicators for initial treatment choice for youth with first episode depression. Specifically, 100 adolescents and young adults (age 12 to 25) with untreated major depressive disorder of recent onset will be randomly allocated in 1:1 ratio to one of two evidence-based regimens for youth depression: (A) Individual cognitive-behavioural therapy; and (B) Optimized pharmacological treatment with an antidepressant. All participants will be offered active treatment for up to 1 year and follow-up for 2 years to establish short- and long-term outcomes, including change in depressive symptoms, maintenance of remission, core role functioning, achievement of educational, occupational and social milestones, and quality of life. Baseline characteristics including duration of untreated depression, pre-existing anxiety, attention-deficit/hyperactivity disorder, substance use, symptoms of reduced interest and activity, sleep, rhythm and melody of speech, brain function, history of childhood adversity, coping style, repetitive thinking, and family history of depression and bipolar disorder will be tested as potential moderators of outcome. Characteristics that differentially predict outcomes in those allocated to initial cognitive-behavioural therapy and those allocated to initial treatment with antidepressants will be combined into a personalized allocation algorithm.

CONDITIONS

Official Title

Treatment Interrupts Depression Early

Who Can Participate

Age: 12Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 12 to 25 years
  • Diagnosis of major depressive disorder with onset within the last 12 months
  • Depression is the main problem needing treatment
  • Moderate or greater depression severity for active treatment (CDRS-R6060606040; MADRS6060606020)
  • Verbal ability adequate for psychological treatment
Not Eligible

You will not qualify if you...

  • History of manic or hypomanic episode
  • Diagnosis of psychotic disorder, pervasive developmental disorder, autism spectrum disorder, or intellectual disability
  • Mental disorders caused by neurological or other medical conditions
  • Active substance use disorder
  • Prior treatment for major depressive disorder lasting 4 weeks or more
  • Current use of antipsychotic, antidepressant, or mood stabilizer medications
  • Recent change (past 6 weeks) in any psychotropic medication or receiving 4 or more CBT sessions
  • Pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Nova Scotia Health

Halifax, Nova Scotia, Canada, B#H 2E2

Actively Recruiting

2

Centre intégré universitaire de santé et de services sociaux de l'Ouest-de-l'Île-de-Montréal / Centre de Recherche Douglas (Montreal West Island IUHSSC / Douglas Research Center)

Montreal, Quebec, Canada, H4H 1R3

Actively Recruiting

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Research Team

R

Rudolf Uher, MD, PhD

CONTACT

J

Jill Cumby, RN, MN

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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Treatment Interrupts Depression Early | DecenTrialz