New ADHD Drug Reduces Symptoms, Improves Social and Family Functioning

November 07, 2001

New York (MedscapeWire) Nov 7 — Atomoxetine hydrochloride significantly reduces core attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents. It also has been shown to improve specific measures of social and family functioning, according to a study published in the November issue of Pediatrics .

"Social and family relationships are very important in a child's daily life and development, and children with ADHD often have trouble in these areas," said David Michelson, MD, medical director at Elly Lilly, the drug's manufacturer, and lead author of the study. "This study supports previous clinical findings that show atomoxetine is effective in reducing core ADHD symptoms. But we also wanted to understand how reducing those symptoms affects quality of life for a child and his or her family. These data suggest there was a significant improvement on specific measures of family and social functioning with atomoxetine."

The 8-week, multicenter, placebo-controlled study is the first to measure the effect of any ADHD treatment on social and family functioning, such as a child's self-esteem, general behavior and the impact of ADHD on the entire family. Previous studies have focused only on the reduction of core ADHD symptoms, such as inattention, hyperactivity, and impulsivity.

Children and adolescents 8 to 18 years old were eligible to participate in the study if they met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for ADHD by clinical assessment, confirmed by structured physician interview.

After an initial 12- to 18-day evaluation and medication washout period, 297 patients were randomized to placebo or atomoxetine dosed on a weight-adjusted basis at either 0.5 mg/kg/day, 1.2 mg/kg/day, or 1.8 mg/kg/day for an 8-week period. Core ADHD symptoms and social and family functioning were assessed using parent and investigator rating scales.

The primary outcome measure for core ADHD symptoms was the ADHD RS, an 18-item scale based on an interview with the patient's primary caretaker. Each item corresponds to 1 of the 18 DSM-IV diagnostic criteria.

Atomoxetine was superior to placebo on the ADHD RS scale in both the 1.2 mg/kg/day and 1.8 mg/kg/day treatment groups. Outcomes were similar for the inattentive and hyperactive/impulsive subscales. Core ADHD symptoms were reduced similarly in younger children compared with older children and adolescents based on the median age split (10.8 years). The 1.2 mg/kg/day dose of atomoxetine appeared to be as effective as 1.8 mg/kg/day and is likely to be the appropriate initial target dose for most patients.

Social and family functioning was measured using the Child Health Questionnaire (CHQ), a set of questions answered by a child's parents or immediate caregiver. The CHQ measures physical and psychosocial well-being in the following areas:

  • Self-esteem (in school, athletic ability, looks/appearance, and the ability to get along with others)

  • General behavior (aggression, delinquency, social withdrawal, and hyperactivity/impulsivity)

  • Impact of a child's ADHD symptoms on family activities

  • Impact on parents' emotions

  • Impact on parents' time.

CHQ summary scores for overall psychosocial functioning indicate that patients receiving atomoxetine achieved statistically significant improvements over those receiving placebo ( P<.05). In addition, atomoxetine was associated with statistically significantly superior outcomes at the 2 higher dose levels on most subscales, such as self-esteem and parents' emotional distress, compared with placebo.

Lilly submitted a new drug application (NDA) for atomoxetine to the US Food and Drug Administration in October. If approved for use, atomoxetine would be the first nonstimulant and the first new type of medication for the treatment of ADHD in more than 30years.

ADHD is a common disorder that affects 3% to 7% of school-age children. It is associated with impairment of academic and social functioning, and a growing body of data suggests that it is also associated with considerable morbidity and poorer outcomes later in life.

Pediatrics 2001;108(5):e83