Personalized treatment for youth with early depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The TIDE project aims to identify personal indicators for selecting initial treatment options for adolescents and young adults experiencing their first episode of major depressive disorder. In this open-label randomized trial, participants aged 12 to 25 will be assigned to either cognitive-behavioral therapy or optimized pharmacological treatment with an antidepressant. The study will follow participants for up to two years to assess changes in depressive symptoms, maintenance of remission, and overall quality of life. Recruitment will occur through various channels, including healthcare providers and social media.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 12-25 years
* Diagnosis of major depressive disorder, onset of the major depressive disorder within the last 12 months. Depression considered the most significant problem in need of treatment.
* An additional inclusion criterion for entering Stage 1 (active intervention) is a minimum moderate depression severity (CDRS-R≥40; MADRS≥20) that justifies the need for treatment. Individuals who fulfill general inclusion criteria but are below the depression severity threshold for active intervention will still be eligible to participate in follow-up assessments.
* Verbal ability sufficient to participate in psychological treatment.

Exclusion Criteria:

* Personal history of a manic or hypomanic episode, diagnosis of a psychotic disorder, pervasive developmental disorder or autism spectrum disorder, intellectual disability, mental disorders secondary to neurological or other medical condition, active substance use disorder.
* Previous trial of any treatment for major depressive disorder lasting 4 weeks or longer, current use of antipsychotic, antidepressant or mood-stabilizer medication.
* Recent (past 6 weeks) change in any psychotropic medication (including stimulants, hypnotics, anxiolytics) or receipt of 4 of more sessions of cognitive-behavioural therapy.
* Pregnancy or breastfeeding. If participants become pregnant or learn of pregnancies during the study, we will consult with Dr. Tanya Tulipan and jointly make the best decision for the participant with the option to either continue or end study treatment.
* No one will be excluded based on sex, gender, race, ethnicity, or living arrangements.

Where it's running

• Nova Scotia Health
  Halifax, Nova Scotia, Canada Recruiting
• 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 Recruiting

Study contacts

• Principal investigator: Rudolf Uher, MD, PhD — Nova Scotia Health Authority
• Study coordinator: Rudolf Uher, MD, PhD
• Email: uher@dal.ca
• Phone: 902-473-7209

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.