Treatment Outcomes in African-American Children with ADHD: METHODS

Patients

Eligible children were 6-12 years of age with a diagnosis of ADHD based on psychiatric history and a review of the DSM-IV diagnostic checklist. Children must have scored >24 on the ADHD-RS at screening and must have been rated “moderately ill” or worse on the CGI-SI. Newly diagnosed treatment-naive patients and previously diagnosed patients who were previously taking some type of ADHD medication but who may not have been receiving adequate treatment as judged by the clinician in conjunction with the parents were eligible for inclusion. Female patients who had experienced menarche were excluded. Patients also were excluded if they had an eating or substance use disorder; a comorbid psychiatric condition other than oppositional defiant disorder; a history of seizures, tic disorder, mental retardation, severe developmental disorder or family history of Tourette’s syndrome; or hyperthyroidism or glaucoma. In addition, patients were excluded if they were receiving a medication that is contraindicated during treatment with OROS MPH or atomoxetine, or if they did not respond to prior treatment for ADHD.

Study Design

This large, multicenter, randomized, open-label, community-based study was conducted among 323 sites. Patients receiving drug therapy for ADHD at enrollment must have discontinued the medication for the greater of three days or five drug half-lives. Eligible patients were randomized in a 2:1 fashion to receive OROS MPH or atomoxetine once daily for 21 days. To directly mimic clinical practice, investigators determined if the starting daily doses of OROS MPH (18 mg) and atomoxetine (0.5 mg/kg) were to be maintained or titrated to higher levels based on assessments made during study visits. Treatment adherence was recorded throughout the study by formal query at each parent/patient contact.
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This study was conducted in accordance with the Declaration of Helsinki and its amendments. Written informed consent or assent was obtained from each patient and parent or guardian before enrollment. An independent, centralized institutional review board reviewed and approved the study protocol prior to the start of the study.

Outcome Measures

Investigators used the Clinical Global Impression-Improvement of Illness (CGI-I) and the ADHD-RS to evaluate effectiveness. The CGI-I is a single rating of improvement that is scored on a seven-point scale (1 = very much improved, 7 = very much worse). The ADHD-RS is the sum of 18 behavioral status scores, which are rated on a scale from 0 (never or rarely) to 3 (very often). The ADHD-RS and the CGI-SI or CGI-I were completed at baseline, by phone (during week 1) and during study visits at weeks 2 and 3. All investigators were chosen on the basis of their extensive experience evaluating and treating patients with ADHD and because their practice sites included a large patient base with ADHD. Prior to the study, all investigators were trained on the use of study instruments using a web-based training course.
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Parents evaluated treatment outcomes using the Parental Satisfaction Questionnaire (PSQ) to rate aspects of the patient’s behavior on a five-point scale from “strongly agree” to “strongly disagree.” Other PSQ statements were rated on a five-point scale from “better than” to “worse than” or as “yes” or “no.” The PSQ was collected daily on days 2-13 and at weeks 2 and 3. The sum of PSQ scores was to be analyzed.

Safety was evaluated by monitoring adverse events, vital signs and body weight. Adverse event monitoring began from the time patients entered the study until the final visit. Study personnel assessed the incidence of adverse events by phone during week 1 and during study visits at weeks 2 and 3 by querying patients to determine the emergence or presence of adverse events. In addition, patients were instructed to immediately report all adverse events to the study center regardless of causality. Study personnel recorded all adverse events. Serious adverse events were defined as those that required hospitalization, prolonged existing hospitalization, resulted in persistent or significant disability or incapacity, were life-threatening or resulted in death or an important medical event. The severity of adverse events was graded as mild, moderate or severe. Investigators assessed the seriousness, clinical severity and relationship of adverse events to study drugs. Going without your pills? Buy cheap orlistat 60 mg online

Statistical Analysis

Descriptive statistics and frequency distributions were used to summarize demographic variables, disease history, baseline characteristics and change from baseline behavior. Analysis of covariance was used to analyze data when baseline values were used as a covariate with treatment as the between-patient factor and visit as a repeated factor. Treatment effects were tested by Chi-squared statistics.