Core set of outcomes for adolescents with major depressive disorder: A tool of standardized outcomes for clinical research

Major depressive disorder (MDD) is a common and serious mental disorder in adolescents. Although advancements in core outcome set (COS) development for adult depression is underway, the type of outcomes measured in MDD trials for adolescents differ from those in adult populations. Currently, there is no core outcome set for effectiveness trials in the treatment of adolescent major depressive disorder.


Principal investigators: Suneeta Monga & Nancy Butcher
Co-investigators: Maureen Smith (patient engagement advisor), Karolin Krause, Martin Offringa, Peter Szatmari
Contributors: Andrea Monsour
Affiliations: Toronto Outcomes Research in Child Health (TORCH), Hospital for Sick Children Research Institute; Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health

Further Study Information

Current Stage: Ongoing
Date: February 2018 - February 2021
Funding source(s): Cundill Centre for Child and Youth Depression

Health Area

Disease Category: Mental health

Disease Name: Major depressive disorder (MDD)

Target Population

Age Range: 12 - 18

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Ethicists
- Governmental agencies
- Journal editors
- Methodologists
- Researchers
- Service providers
- Statisticians

Study Type

- COS for clinical trials or clinical research


- Consensus conference
- Delphi process
- Interview
- Survey
- Systematic review

Development of this COS will follow Core Outcome Set-STAndards for Development (COS-STAD) guidelines. To identify existing knowledge about outcomes in adolescent MDD and establish the need for a COS, a systematic scoping review will be conducted. Once outcomes are mapped to an outcome-related framework (e.g., OMERACT filter 2.0), a Delphi process will be conducted to determine which outcomes are core or essential to retain for final discussion at a face-to-face consensus meeting and patient/caregiver interviews. At these final discussions, outcomes will be selected to include in the final COS.