PMID- 17343551 OWN - NLM STAT- MEDLINE DCOM- 20070530 LR - 20131121 IS - 1044-5463 (Print) IS - 1044-5463 (Linking) VI - 17 IP - 1 DP - 2007 Feb TI - A pilot evaluation of the safety, tolerability, pharmacokinetics, and effectiveness of memantine in pediatric patients with attention-deficit/hyperactivity disorder combined type. PG - 19-33 AB - BACKGROUND: Disturbances in N-methyl-D-aspartate (NMDA) receptor activity may play a role in attention-deficit/hyperactivity disorder (ADHD). OBJECTIVE: This study is a preliminary evaluation of the safety, pharmacokinetics, and effectiveness of the NMDA receptor antagonist memantine in pediatric ADHD. METHODS: An open-label, dose-finding, 8-week, trial in outpatients 6-12 years old with ADHD combined type. Memantine oral solution (2 mg/mL) was titrated to 10 mg/day (n = 8) or 20 mg/day (n = 8). Safety data and blood samples for pharmacokinetic analyses were collected. The ADHD Rating Scale-IV (ADHD-IV) and Clinical Global Impression of Severity (CGI-S) scale measured the effectiveness of memantine. RESULTS: There were no discontinuations due to adverse events (AEs), serious AEs, deaths, or suicides. Most AEs were mild and occurred during the first week of treatment. The 20 mg/day memantine dose was associated with a higher rate of completion and larger mean improvement on the ADHD-IV and CGI-S than 10 mg/day memantine. Pharmacokinetic analyses suggest response to memantine may be dose-dependent beyond an initial threshold concentration. CONCLUSIONS: This pilot study suggests that a memantine dose of 20 mg/day may be a safe and possibly effective treatment for pediatric ADHD. Further investigations of memantine in ADHD appear to be warranted. FAU - Findling, Robert L AU - Findling RL AD - Department of Psychiatry, Case Western Reserve University and Division of Child & Adolescent Psychiatry, University Hospitals of Cleveland, Cleveland, Ohio 44106-5080, USA. Robert.Findling@uhhs.com FAU - McNamara, Nora K AU - McNamara NK FAU - Stansbrey, Robert J AU - Stansbrey RJ FAU - Maxhimer, Rebecca AU - Maxhimer R FAU - Periclou, Antonia AU - Periclou A FAU - Mann, Allison AU - Mann A FAU - Graham, Stephen M AU - Graham SM LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - J Child Adolesc Psychopharmacol JT - Journal of child and adolescent psychopharmacology JID - 9105358 RN - 0 (Receptors, N-Methyl-D-Aspartate) RN - W8O17SJF3T (Memantine) SB - IM MH - Administration, Oral MH - Attention Deficit Disorder with Hyperactivity/blood/*drug therapy MH - Child MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Male MH - Memantine/*administration & dosage/adverse effects/pharmacokinetics MH - Pilot Projects MH - Receptors, N-Methyl-D-Aspartate/*antagonists & inhibitors MH - Treatment Outcome EDAT- 2007/03/09 09:00 MHDA- 2007/05/31 09:00 CRDT- 2007/03/09 09:00 PHST- 2007/03/09 09:00 [pubmed] PHST- 2007/05/31 09:00 [medline] PHST- 2007/03/09 09:00 [entrez] AID - 10.1089/cap.2006.0044 [doi] PST - ppublish SO - J Child Adolesc Psychopharmacol. 2007 Feb;17(1):19-33. doi: 10.1089/cap.2006.0044.