Functional impairment outcomes in clinical trials of different ADHD medications: post hoc responder analyses and baseline subgroup analyses

• Published in: European child & adolescent psychiatry 2021-05, Vol.30 (5), p.809-821
• Main Authors: Coghill, David R., Werner-Kiechle, Tamara, Farahbakhshian, Sepehr, Bliss, Caleb, Robertson, Brigitte, Huss, Michael
• Format: Article
• Language: English
• Subjects: Adolescent; Attention Deficit Disorder with Hyperactivity - drug therapy; Attention Deficit Disorder with Hyperactivity - psychology; Attention deficit hyperactivity disorder; Child; Child & adolescent psychiatry; Child and Adolescent Psychiatry; Clinical research; Clinical trials; Double-Blind Method; Drugs; Female; Functional impairment; Humans; Hyperactivity; Male; Medicine; Medicine & Public Health; Oppositional defiant disorder; Original Contribution; Placebos; Psychiatry; Quality of life; Quality of Life - psychology; Social activities; Social discrimination learning; Treatment Outcome
• ISSN: 1018-8827; 1435-165X
• DOI: 10.1007/s00787-020-01586-5

Several recent phase 3 clinical trials of attention-deficit/hyperactivity disorder (ADHD) medications have used the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P). Here, we assess WFIRS-P response in individual patients in two pivotal trials of lisdexamfetamine dimesylate (LDX) and guanfacine extended release (GXR). We also analysed pooled WFIRS-P data from seven phase 3 studies of ADHD medications to shed light on factors associated with baseline functional impairment. The proportion of patients with a change in WFIRS-P score that exceeded the minimal important difference (MID) criteria for response was greater for LDX than placebo in the Family, Learning and School, and Risky Activities domains, and was greater for GXR than placebo in the Social Activities, Learning and School, and Family domains. Responders had significantly worse baseline scores in all WFIRS-P domains (all p