Effectiveness of Methylphenidate in the 10-Month Continuation Phase of the Preschoolers with ADHD Treatment Study (PATS) (original) (raw)
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Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers With ADHD
Journal of the American Academy of Child & Adolescent Psychiatry, 2006
Objective: The Preschool ADHD Treatment Study (PATS) was a NIMH-funded, six-center, randomized, controlled trial to determine the efficacy and safety of immediate-release methylphenidate (MPH-IR), given t.i.d. to children ages 3 to 5.5 years with attention-deficit/hyperactivity disorder (ADHD). Method: The 8-phase, 70-week PATS protocol included two double-blind, controlled phases, a crossover-titration trial followed by a placebo-controlled parallel trial. The crossovertitration phase`s primary efficacy measure was a combined score from the Swanson, Kotkin, Atkins, M-Flynn, and Pelham (SKAMP) plus the Conners, Loney, and Milich (CLAM) rating scales; the parallel phase`s primary outcome measure was excellent response, based on composite scores on the Swanson, Nolan, and Pelham (SNAP) rating scale. Results: Of 303 preschoolers enrolled, 165 were randomized into the titration trial. Compared with placebo, significant decreases in ADHD symptoms were found on MPH at 2.5 mg (p G .01), 5 mg (p G .001), and 7.5 mg (p G .001) t.i.d. doses, but not for 1.25 mg (p G .06). The mean optimal MPH total daily dose for the entire group was 14.2 T 8.1 mg/day (0.7 T 0.4 mg/kg/day).
Journal of attention disorders, 2014
To evaluate the long-term effects of methylphenidate imediate-release (MPH-IR), and to confirm the efficacy established in previous meta-analyses of short-term studies. Published and unpublished studies in which participants were treated with MPH-IR for 12 weeks or more were searched. Pooled effect sizes from these studies were computed with the DerSimonian and Laird random-effect model. Meta-regression analysis was conducted to estimate covariates associated with treatment effects. Seven studies were included. Pooled parents ratings for inattention and hyperactivity/impulsivity resulted in standardized mean difference (SMD) = 0.96 (95% confidence interval [CI] = [0.60, 1.32]) and SMD = 1.12 (95% CI = [0.85, 1.39]), respectively; pooled teachers ratings showed SMD = 0.98 (95% CI = [0.09, 1.86]) for inattention and SMD = 1.25 (95% CI = [0.7, 1.81]) for hyperactivity/impulsivity. No evidence of association of any covariates with treatment effect was detected in the meta-regression. MP...
Safety and Tolerability of Methylphenidate in Preschool Children With ADHD
Journal of the American Academy of Child & Adolescent Psychiatry, 2006
Objective: To report on the safety and tolerability of methylphenidate (MPH) 3-to 5-year-old children with attention-deficit/ hyperactivity disorder (ADHD) during 1 year of treatment. Method: Exactly 183 children (3Y5 years old) entered a treatment study of MPH, consisting of a 1-week open-label lead-in (n = 183); a 5-week placebo-controlled, double-blind phase (n = 165); a 5-week double-blind, parallel phase (n = 114); and 10 months of open-label maintenance (n = 140 entered, 95 completed). Mean total daily MPH doses rose from the titration trial best dose, 14.1 (T8.1) mg/day, to 20.5 (T9.7) mg/day mean total daily dose at the end of maintenance. Pulse, blood pressure, and the presence of treatment emergent adverse events (AEs), parent and teacher AE ratings, and vital signs were recorded in each phase. Results:
Journal of Child and Adolescent Psychopharmacology, 2009
Objective: The aim of this study was to investigate the short-term efficacy and safety of methylphenidate (MPH) to treat attention-deficit=hyperactivity disorder (ADHD) symptoms in an understudied population of preschoolers with pervasive developmental disorder (PDD) or intellectual disability (ID). Methods: Fourteen preschoolers with developmental disorders (DD, n ¼ 14; PDD, n ¼ 12; ID, n ¼ 2) underwent MPH titration in a single-blind manner followed by a 4-week double-blind crossover phase. Each child was administered placebo for 2 weeks and ''optimal dose'' for 2 weeks. The primary outcome measure was the Diagnostic and Statistical Manual of Mental Disorders, 4 th edition (DSM-IV) ADHD subscale of the Conners' Parent Rating Scale-Revised (CPRS-R-DSM-IV-ADHD). Results: MPH improved parent-rated ADHD symptoms of the preschoolers; 50% were rated as responders. The CPRS-R-DSM-IV-ADHD subscale was significant for the PDD subgroup ( p ¼ 0.005, Cohen d ¼ 0.97) and marginally significant for the entire DD sample ( p ¼ 0.08, Cohen d ¼ 0.50). Half of the preschoolers experienced side effects with MPH, including reports of increased stereotypic behavior, upset stomach, sleep-related difficulties, and emotional lability. One child discontinued during titration due to side effects. Conclusion: The predominant direction of response in these preschoolers with both ADHD and PDD=ID favored MPH, even though the response was more subtle and variable than in older and typically developing children. Due to high rates of adverse effects, preschoolers should be monitored closely.
Neuropsychiatric Disease and Treatment, 2013
Background: The purpose of this multicenter Spanish study was to evaluate the response to immediate-release methylphenidate by children and adults diagnosed with attention-deficit/ hyperactivity disorder (ADHD), as well as to obtain information on current therapy patterns and safety characteristics. Methods: This multicenter, observational, retrospective, noninterventional study included 730 patients aged 4-65 years with a diagnosis of ADHD. Information was obtained based on a review of medical records for the years 2002-2006 in sequential order. Results: The ADHD predominantly inattentive subtype affected 29.7% of patients, ADHD predominantly hyperactive-impulsive was found in 5.2%, and the combined subtype in 65.1%. Overall, a significant lower Clinical Global Impression (CGI) score and mean number of DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) symptoms by subtype were found after one year of treatment with immediaterelease methylphenidate; CGI decreased from 4.51 to 1.69, symptoms of inattention from 7.90 to 4.34, symptoms of hyperactivity from 6.73 to 3.39, and combined subtype symptoms from 14.62 to 7.7. Satisfaction with immediate-release methylphenidate after one year was evaluated as "very satisfied" or "satisfied" by 86.90% of the sample; 25.75% of all patients reported at least one adverse effect. At the end of the study, 41.47% of all the patients treated with immediate-release methylphenidate were still receiving it, with a mean time of 3.80 years on therapy. Conclusion: Good efficacy and safety results were found for immediate-release methylphenidate in patients with ADHD.
PEDIATRICS, 2002
Objective. To compare the efficacy, safety, and tolerability of once-daily administration of modified-release methylphenidate (MPH MR) with placebo in children with attention-deficit/hyperactivity disorder (ADHD). Methods. The study was a 3-week, double-blind, 32site, randomized clinical trial comparing MPH MR with placebo. Children were 6 to 16 years of age, had a diagnosis of ADHD, and had not failed a previous trial of stimulant treatment for ADHD. After a 1-week, singleblind, placebo-washout period, participants received a once-daily dose of MPH MR or placebo, which was started with 1 capsule (20 mg) and individually titrated up to a maximum of 3 capsules (60 mg). The primary outcome measure was specified as a reduction in ADHD symptom severity from the teacher version of the 10-item Conners' Global Index. Investigators, teachers, and parents evaluated safety. Results. The study randomized 321 children: 158 to MPH MR and 163 to placebo. Children in the MPH MR group were started on a dose of 20 mg/d and reached a mean dose of 40.7 mg/d (1.28 mg/kg/d) at endpoint. Compared with placebo, MPH MR significantly reduced ADHD symptoms ratings on the teacher version of the 10-item Conners' Global Index, on the parent version of the Conners' Global Index, on the parent assessment of global efficacy, and on investigator assessment of global improvement. The most common adverse events in the MPH MR group were headache, anorexia, abdominal pain, and insomnia. Only anorexia occurred at a rate that was significantly greater than placebo. Conclusion. MPH MR administered once daily in the morning is effective and safe in controlling ADHD symptoms throughout the school day.
The present study was designed to study the efficacy and tolerability of methylphenidate in Indian children with Attention Deficit Hyperactivity Disorder (ADHD). Drug naïve patients, 52 in number were recruited for this study. The CGI scale and Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS) was used to access the efficacy and tolerability of methylphenidate over a period of 12 weeks. Methylphenidate was found to be an efficacious drug in Indian children with ADHD as assessed with scores of Vanderbilt and CGI scale in all the subgroups.