Pilot Phase II study of mazindol in children with attention deficit/hyperactivity disorder

• Published in: Drug design, development and therapy development and therapy, 2014, Vol.8 (default), p.2321-2332
• Main Authors: Konofal, Eric, Zhao, Wei, Laouénan, Cédric, Lecendreux, Michel, Kaguelidou, Florentia, Benadjaoud, Lila, Mentré, France, Jacqz-Aigrain, Evelyne
• Format: Article
• Language: English
• Subjects: ADHD; Adolescent; Appetite loss; Attention Deficit Disorder with Hyperactivity - drug therapy; Attention deficit hyperactivity disorder; Care and treatment; Child; Children; Dopamine; Dosage and administration; Drug Administration Schedule; efficacy; Fat-free body mass; Female; Humans; Hyperactivity; Hypertension; Impulsivity; Laboratories; Lag time; Male; Mazindol; Mazindol - administration & dosage; Mazindol - adverse effects; Mazindol - pharmacokinetics; Mazindol - therapeutic use; Mental disorders; Original Research; Pain; Parents & parenting; Pediatrics; Pharmacokinetics; Pharmacology; Pilot Projects; Safety; Signs and symptoms; Sleep disorders; Statistical methods; Therapeutic applications; Weight reducing preparations
• ISSN: 1177-8881; 1177-8881
• DOI: 10.2147/DDDT.S65495

Mazindol has been proposed as a potential treatment of children with attention deficit/hyperactivity disorder (ADHD). The purpose of this pilot study was to assess its pharmacokinetics, short-term efficacy, and safety. A total of 24 children (aged 9-12 years) with ADHD (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text-revision criteria) received a daily dose of 1 mg for 7 days and were followed for 3 additional weeks. Pharmacokinetic samples were collected after the first administration. ADHD symptoms were assessed using the ADHD Rating Scale (RS)-IV, Conners' Parent Rating Scale - Revised: Long (CPRS-R:L) at screening, baseline, and the end of the study. The Clinical Global Impression - Severity (CGI-S) scale was assessed at baseline, and the CGI - Improvement (CGI-I) scale was assessed at subsequent visits. Twenty-one subjects (aged 10±1 years) were analyzed. Pharmacokinetic data were described by a one-compartment model with first-order absorption, elimination, and lag time. The typical apparent clearance and apparent volume of distribution were 27.9 L/h and 234 L, and increased with fat-free mass and age, respectively. The mean change in score in ADHD RS-IV after 1 week of mazindol was -24.1 (P