Clinical trial Recruiting at 1 site Interventional Ages 13 to 18

Evaluating an Integrated Care Pathway for treating adolescent depression

Official title: Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial

Run by Centre for Addiction and Mental Health · NCT05142683 · Data updated 2026-11-12

This study is testing a new treatment approach for teens aged 13 to 18 with depression to see if it helps them feel better compared to the usual care they receive.

Quick facts

Study typeInterventional
Ages13 Years to 18 Years
SexAll
Enrollment300 (estimated)
SponsorCentre for Addiction and Mental Health
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedFebruary 1, 2022
Main results expectedSeptember 30, 2027
Study endsSeptember 30, 2027
Registry record updatedAugust 20, 2026
Trial IDNCT05142683 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adolescents aged 13 to 18 who present with depressive symptoms and have a Mood and Feelings Questionnaire score of 22 or higher.

Probably not a fit

Patients with severe mental health conditions such as psychosis, severe substance use disorders, or those currently in day treatment may not benefit from this study.

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

What this trial studies

This clinical trial investigates the effectiveness of an Integrated Care Pathway (ICP) for adolescents aged 13 to 18 with major depressive disorder, comparing it to Treatment As Usual (TAU). The study employs a stepped wedge cluster randomized controlled design across six community mental health agencies, where all sites will initially provide TAU before transitioning to the ICP in a randomized sequence. The primary goal is to assess the clinical improvement in depressive symptoms and functioning among participants receiving the ICP. Additionally, the study will evaluate the feasibility, fidelity, cost, and acceptability of implementing the ICP in community settings.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for adolescents suffering from depression.

How similar studies have gone: Previous studies have shown promise in using Integrated Care Pathways for adolescent depression, but this specific approach is being tested in a community setting for the first time.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Youth is aged 13 to 18 years, inclusive.
* Youth and/or their caregiver is expressing that 'depression" (or some synonym) is a concern.
* Clinician agrees that depressive symptoms are a treatment target.
* Mood and Feelings Questionnaire score is ≥22 at two sequential visits (screening and baseline assessment).
* Youth must be new to the site (in past 3 months) or have a period of no treatment for 3 months

Exclusion Criteria:

* Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour.
* Severe substance use disorder, bipolar disorder, autism spectrum disorder or intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization as per judgment of the assessing clinician.
* Inability to provide informed consent to the study for any reason
* Youth currently in Day Treatment

Where it's running

  • Centre for Addiction and Mental Health
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Dupilumab for Major Depressive Disorder

    This study tests whether dupilumab can engage immune targets in adults with major depressive disorder to see if it can help with depressive symptoms.

    Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07908563

  • Accelerated vs Standard iTBS for Major Depression

    This trial tests whether giving more accelerated iTBS sessions is better tolerated and more effective than the standard schedule for adults with major depressive disorder.

    Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07768397

  • Psilocybin with Structured Integrated Reframing Therapy for trauma-related MDD and PTSD

    This trial tests whether psilocybin therapy, alone or with Structured Integrated Reframing Therapy (SIRT), helps people with trauma-related major depressive disorder who are already on a stable antidepressant.

    Recruiting Phase 3 Khyber Medical University Peshawar · Islamabad, Capital and 2 other locations · NCT07703722

  • Magnesium Bisglycinate Added to Your Depression Treatment

    This study tests whether adding magnesium bisglycinate to your current antidepressant can help reduce depressive symptoms and improve sleep and daily functioning for adults with major depressive disorder.

    Recruiting All India Institute of Medical Sciences, Bhubaneswar · Bhubaneswar, Odisha · NCT07633080

  • Motif XCS System for treatment-resistant depression

    This study tests whether the Motif XCS System is safe and tolerable and might help people with treatment-resistant major depressive disorder.

    Recruiting at 4 sites Motif Neurotech, Inc. · Atlanta, Georgia and 3 other locations · NCT07594483

  • A Phase 3 test of DT120 for major depressive disorder

    DT120 is tested against placebo in adults with major depressive disorder to see if it can help reduce depressive symptoms.

    Recruiting at 23 sites Phase 3 Definium Therapeutics US, Inc. · Little Rock, Arkansas and 25 other locations · NCT07592689

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.