Placebo-controlled evaluation of amphetamine mixture-dextroamphetamine salts and amphetamine salts (Adderall): efficacy rate and side effects
| Autor: | Fred W. Theye, Ann J. Linquist, Lois R. Campbell, Alayne J. Van Erem, Peter A. Ahmann, Richard L. Berg |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Adolescent Population Placebo law.invention Randomized controlled trial Double-Blind Method law Medicine Attention deficit hyperactivity disorder Humans Prospective Studies education Psychiatry Amphetamine Child education.field_of_study Likelihood Functions business.industry Amphetamines medicine.disease Crossover study Clinical trial Treatment Outcome Stomachaches Attention Deficit Disorder with Hyperactivity Pediatrics Perinatology and Child Health Central Nervous System Stimulants Female business medicine.drug |
| Zdroj: | Pediatrics. 107(1) |
| ISSN: | 1098-4275 |
| Popis: | Objective.The primary objective of this study was to determine the efficacy rate of Adderall in children newly diagnosed with attention-deficit/hyperactivity disorder (ADHD). A secondary objective was to address the severity of side effects associated with Adderall treatment in children with ADHD using the Barkley Side Effects Questionnaire (BSEQ).Design.Randomized, double-blind, placebo-controlled crossover trial.Setting.A large rural tertiary care clinic.Patients.Participants were prospectively recruited from children 5 to 18 years of age referred for academic and/or attention problems; 154 children who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD were enrolled.Interventions.Two doses of Adderall (0.15 mg/kg/dose and 0.3 mg/kg/dose) were compared with placebo in separate 2-week trials. Participants received each dosage regimen twice daily for 7 consecutive days.Measurements and Main Results.Efficacy rates were determined by comparing Adderall with placebo during the low-dose crossover sequence and also during the high-dose crossover sequence. The criteria that defined a positive response to Adderall relative to placebo (with each patient serving as their own control) included an indication of response by at least 1 of 2 parent measures of children's behavior or at least 2 of 5 teacher measures of children's behavior. The Adderall efficacy rate was determined based on parent criteria alone, teacher criteria alone, and by a more stringent definition of response that required concurrence between parent and teacher criteria. The Adderall response rate in this study ranged from 59% when requiring concurrence between parent and teacher observers, to 82% when based on parent criteria alone. Overall, 137 of 154 participants (89%) showed a positive response by either the parent or teacher response criteria.Parents completed a modified version of the BSEQ during each week of the trial. Appetite, stomachaches, and insomnia were rated as worse by parents while children were receiving either dose of Adderall; headaches were rated as worse when children were receiving the higher dose of Adderall. Parents rated certain side effects, including staring/daydreaming, sadness, euphoria, and anxious/irritable, as worse during placebo regimens.Conclusions.We found that Adderall is highly efficacious in our population of youth diagnosed with ADHD. In addition, Adderall is well-tolerated with a side effect profile similar to that reported for other psychostimulants. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|