A systematic review of the characteristics of adolescents with major depressive disorder in randomised controlled treatment trials

Abstract Background and Objectives Concerns exist around the generalizability of randomised controlled trials (RCTs) for adolescents with major depressive disorder (MDD). This review assesses whether adolescents with MDD treated in RCTs are representative of clinical samples. Methods A systematic narrative review of selection criteria used in RCTs for adolescent MDD (PROSPERO CRD42018096298). Included were studies assessing psychological, pharmacological or combination treatments. Results 52 studies were included. Overall, the reporting of selection criteria (defined as both inclusion and exclusion criteria), in the 23 psychotherapy trials was low (52% did not report on comorbid emotional disorders and 48% did not report on suicidal ideation). In contrast, the majority of selection criteria were reported in the 22 medication trials and the 7 combination trials. Where selection criteria were reported, most adolescents with comorbidities were excluded from psychotherapy and medication trials. The 7 combination trials included more adolescents with comorbidities. Of note, only 10 of the 52 studies reported on self-harm as a selection criteria. Conclusion Reporting of the characteristics of depressed adolescents was poor in psychotherapy trials. Both psychotherapy and medication trials excluded many adolescents with co-morbid conditions, however combination trials tended to be more inclusive. There is concern that many RCTs for adolescent MDD may not be generalizable to clinical populations, particularly with regards to comorbidity, self-harm and suicidal ideation. The findings suggest that clinicians need to view the evidence base and guidelines developed from RCTs with discernment. Pragmatic trials are needed with representative clinical populations and comprehensive reporting of the selection criteria.