title: Effectiveness and safety of donepezil in boys with fragile x syndrome: a double-blind, randomized, controlled pilot study.
abstract: The present study was designed as a 12-week, randomized, double-blind, placebo-controlled pilot study to evaluate the effectiveness and safety of donepezil in boys with fragile X syndrome. Twenty boys with fragile X syndrome were randomized to receive 12 weeks of treatment with either placebo or donepezil (2.5 mg daily for initial 4 weeks followed by 5 mg daily for next 8 weeks). The outcome measures included change in intelligence quotient scores on Stanford-Binet Intelligence Scale (Hindi adaptation by Kulshrestha), change in behavioral scores by Conners 3 Parent Rating Scale (Short) and Childhood Autism Rating Scale, safety, and tolerability of donepezil. The study failed to show significant difference in intelligence quotient and behavioral scales with donepezil therapy over 12 weeks. However, donepezil appeared to be safe and well tolerated.
authors: Department of Pediatrics, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
authors: Jitendra Kumar
authors: JK
authors: Sahu
authors: Sheffali
authors: S
authors: Gulati
authors: Savita
authors: S
authors: Sapra
authors: Ravindra
authors: R
authors: Arya
authors: Sandeepa
authors: S
authors: Chauhan
authors: Madhumita Roy
authors: MR
authors: Chowdhury
authors: Neerja
authors: N
authors: Gupta
authors: Madhulika
authors: M
authors: Kabra
authors: Y K
authors: YK
authors: Gupta
authors: S N
authors: SN
authors: Dwivedi
authors: Veena
authors: V
authors: Kalra
mesh_terms: D000293:Adolescent; D002648:Child; D002653:Child Behavior Disorders / Q000175:diagnosis / Q000188:drug therapy; D002659:Child Development Disorders, Pervasive / Q000175:diagnosis / Q000188:drug therapy; D000077265:Donepezil; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005600:Fragile X Syndrome / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007189:Indans / Q000009:adverse effects* / Q000627:therapeutic use*; D007360:Intelligence / Q000187:drug effects; D008297:Male; D018697:Nootropic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D010552:Personality Assessment; D010865:Pilot Projects; D010880:Piperidines / Q000009:adverse effects* / Q000627:therapeutic use*; D013195:Stanford-Binet Test; D016896:Treatment Outcome
chemical_list: D007189:Indans; D018697:Nootropic Agents; D010880:Piperidines; D000077265:Donepezil