Buspirone versus Methylphenidate in the Treatment of Children with Attention- Deficit/ Hyperactivity Disorder: Randomized Double-Blind Study
AbstractA recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for < 30kg and 30 mg/day for > 30kg) (group 1) or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for < 30kg and 30 mg/day for > 30kg (group 2) for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD) and -15.60±7.81 (mean±SD) for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD) and -22.40±9.90 (mean±SD) for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of buspirone was less effective than methylphenidate in the treatment of ADHD.
May DE, Kratochvil CJ. Attention-deficit hyperactivity disorder: recent advances in pediatric pharmacotherapy. Drugs 2010; 70(1):15-40.
Noorbala AA, Akhondzadeh S. Attentiondeficit/hyperactivity disorder: etiology and pharmacotherapy. Arch Iran Med 2006, 9(4):374-80.
Mohammadi MR, Akhondzadeh S. Pharmacotherapy of attention-deficit/hyperactivity disorder: nonstimulant medication approaches. Exp Rev Neurotrapeutics 2007; 7(2):195–201.
Cormier E. Attention deficit/hyperactivity disorder: a review and update. J Pediatr Nurs 2008; 23(5):345-57.
Mohammadi M, Akhondzadeh S. Advances and considerations in attention-deficit/hyperactivity disorder pharmacotherapy. Acta Med Iran 2011; 49(8):487-98.
Banaschewski T, Roessner V, Dittmann RW, Santosh PJ, Rothenberger A. Non-stimulant medications in the treatment of ADHD. Eur Child Adol Psychiatry 2004; 13 Suppl 1:102-16.
Sanghera MK, McMillen BA, German DC. Buspirone, a non-benzodiazepine anxiolytic, increases locus coeruleus noradrenergic neuronal activity. Eur J Pharmacol 1982, 86(1):107–10
Malhotra S, Santosh PJ. An open clinical trial of buspirone in children with attention deficit/hyperactivity disorder. J Am Acad Child Adol Psychiatry 1998; 37(4):364–71.
Davari-Ashtiani R, Shahrbabaki ME, Razjouyan K, Amini H, Mazhabdar H. Buspirone versus methylphenidate in the treatment of attention deficit hyperactivity disorder: a double-blind and randomized trial. Child Psychiatry Hum Dev 2010 41(6):641-8.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition. Washington, DC: American Psychiatric Association; 2000. Text Revision.
Ghanizadeh A, Mohammadi MR, Yazdanshenas A. Psychometric properties of the Farsi translation of the Kiddie Schedule for Affective Disorders and Schizophrenia- Present and Lifetime Version. BMC Psychiatry 2006; 15(6):10.
DuPaul G, Power T, Anastopoulos A, Reid R. ADHD Rating Scale-IV. New York: Guilford; 1998.
Akhondzadeh S, Tavakolian R, Davari- Ashtiani R, Arabgol F, Amini H. Selegiline in the treatment of attention deficit hyperactivity disorder in children: a double blind and randomized trial. Prog. Neuro- Psychopharmacol Biol Psychiatry 2003; 27(5):841–5.
Mohammadi M, Kashani L, Akhondzadeh S, Sahimi Izadian E, Ohadinia S. Efficacy of theophylline compared to methylphenidate for the treatment of attention deficit hyperactivity disorder in children and adolescents: A double blind and randomized trial. J Clin Pharm Ther 2004; 29(2):139-44.
Zarinara AR, Mohammadi MR, Hazrati N, Tabrizi M, Rezazadeh SA, Rezaie F, Akhondzadeh S. Venlafaxine versus methylphenidate in pediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial. Hum Psychopharmacol 2010; 25(7-8):530-5.
Mohammadi MR, Kazemi MR, Zia E, Rezazadeh SA, Tabrizi M, Akhondzadeh S. Amantadine versus methylphenidate in children and adolescents with attention deficit/hyperactivity disorder: a randomized, double-blind trial. Hum Psychopharmacol 2010; 25(7-8):560-5.
Kahbazi M, Ghoreishi A, Rahiminejad F, Mohammadi MR, Kamalipour A, Akhondzadeh S. A randomized, double-blind and placebo-controlled trial of modafinil in children and adolescents with attention deficit and hyperactivity disorder. Psychiatry Res 2009; 168(3):234-7.
Amiri S, Mohammadi MR, Mohammadi M, Nouroozinejad GH, Kahbazi M, Akhondzadeh S. Modafinil as a treatment for Attention- Deficit/Hyperactivity Disorder in children and adolescents: a double blind, randomized clinical trial. Prog Neuropsychopharmacol Biol Psychiatry 2008; 32(1):145-9.
Salehi B, Imani R, Mohammadi MR, Fallah J, Mohammadi M, Ghanizadeh A, Tasviechi AA, Vossoughi A, Rezazadeh SA, Akhondzadeh S. Ginkgo biloba for attention-deficit/hyperactivity disorder in children and adolescents: a double blind, randomized controlled trial. Prog Neuropsychopharmacol Biol Psychiatry 2010; 34(1):76-80
Abbasi SH, Heidari S, Mohammadi MR, Tabrizi M, Ghaleiha A, Akhondzadeh S. Acetyl-L-carnitine as an adjunctive therapy in the treatment of attentiondeficit/ hyperactivity disorder in children and adolescents: a placebo-controlled trial. Child Psychiatry Hum Dev 2011; 42(3):367-75.
Jafarinia M, Mohammadi MR, Modabbernia A, Ashrafi M, Khajavi D, Tabrizi M, Yadegari N, Akhondzadeh S.. Bupropion versus methylphenidate in the treatment of children with attention-deficit/hyperactivity disorder: randomized double-blind study. Hum Psychopharmacol 2012 27(4):411-8..