Personalized treatment for youth with early depression
Treatment Interrupts Depression Early
This study is testing whether personalized treatment options, like therapy or medication, can help young people aged 12 to 25 who are dealing with their first episode of depression feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 2 sites (Halifax, Nova Scotia and 1 other locations) |
| Trial ID | NCT05002309 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults aged 12 to 25 with a recent diagnosis of major depressive disorder.
Not a fit: Patients with a history of manic episodes, psychotic disorders, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for young individuals suffering from depression.
How similar studies have performed: Other studies have shown success with similar personalized treatment approaches for depression, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Halifax, Nova Scotia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.