Based on clinical assessments after oral administration of mazindol to 24 children (9-12 years) with ADHD (according to DSM-IVTR criteria), this open-label study evaluates the efficacy, safety and tolerability of mazindol (1 mg/d, 7 days). Safety evaluations included routine hematology, electrocardiograms, blood pressure, and pulse rate. Efficacy rating measurements included ADHD-RS score (primary outcome measure), CPRS-R:L, CGI-S and CGI-I (secondary outcome measures). This clinical trial reports data obtained from 21 boys (10 ¡À 1 years).
Based on primary outcome (ADHD-RS), change in ADHD-RS mean total score after one week of mazindol was ?4.6 (p < 0.0001) ; greater than a 90 % improvement from baseline. Change in CPRS-R:L (80 items) mean total score after one week of mazindol was ?5.5 (p < 0.0001); CGI-S after one week of mazindol was -3,02 (p< 0.01). Adverse events were mild to moderate in severity and decreased appetite, weight loss, headache, and abdominal pain were most common (95 % ).
Changes in laboratory values, ECG, blood pressure, pulse rate and body weight were not clinically meaningful. Blood pressure and pulse rate were unchanged (p > 0.05) after one week of treatment.
This preliminary investigation suggests that mazindol is still a new well-tolerated and active psychostimulant for the treatment of ADHD in children.