Systematic scoping review identifies heterogeneity in outcomes measured in adolescent depression clinical trials.

Abstract Objective The objective of this review was to identify outcomes reported in adolescent major depressive disorder trials and quantify outcome heterogeneity. Study Design and Setting Three databases were searched to identify trials evaluating therapies for major depressive disorder in adolescents published from 2008-2017. Identified outcomes were thematically grouped and mapped into predefined outcome core areas (Physiological/Clinical, Life Impact, Resource Use, Adverse Events, and Death). Outcome heterogeneity was quantified using descriptive analyses. Results Of 2686 articles yielded from the search, 42 articles describing 32 trials were included. A total of 434 outcomes measured using 118 different outcome measurement instruments were grouped into 86 unique outcome terms. The majority of outcome terms mapped to the Physiological/Clinical core area (62%), followed by the Life Impact (27%). Nearly half (45%) were reported in only a single trial each. Of 18 primary outcomes reported, 13 (72%) were each only reported in a single trial. “Depressive symptom severity”, reported in 30 trials (94%), was measured using 19 different outcome measurement instruments. Conclusion Heterogeneity exists in the outcomes and outcome measurement instruments used in adolescent depression trials. To enable reproducibility, comparison, and synthesis of trial results, a standard set of agreed upon outcomes and methods of measurement is needed.