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Once-daily Atomoxetine Associated With Continuous Relief of Attention Deficit/Hyperactivity Disorder Symptoms: Presented at AACAP

By Paula Moyer

MIAMI BEACH, FL -- October 28, 2003 -- Children with attention deficit hyperactivity disorder (ADHD) who receive treatment with the once-daily formulation of atomoxetine (Strattera) have continuous relief of symptoms, as seen by evening and morning behavioural assessments.

These findings were presented here October 16^th at the 50^th anniversary of the American Academy of Child and Adolescent Psychiatry.

"This is a different type of medication than any other that we have used to treat ADHD for the past 30 years," said principal investigator Douglas Kelsey, MD, PhD. "It is effective, and one of the ways that parents can see its effectiveness is by deciding [to focus on] 2 or 3 behavioural issues…as goals." Dr. Kelsey is a paediatric clinical research physician, Lilly Technology Center, Indianapolis, Indiana, United States.

The 197 children in the study ranged in age from 6 to 12 years old, and had been previously diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). The participants were randomised to receive either atomoxetine or placebo for 8 weeks. The parents evaluated the children's behaviour in the evening and in the early morning. The final average daily dose in the treatment arm was 1.3 mg/kg daily.

Among the children, 71% were boys; 69% of the subjects had a mixed subtype of ADHD, consisting of both inattention and hyperactivity and impulsivity. The most common co-morbidity in the group was oppositional defiant disorder, which was present in 35% of children.

The investigators found that treatment with the once-daily atomoxetine formulation was significantly more effective at treating core ADHD symptoms, according to Dr. Kelsey. This efficacy was seen at the evening assessment -- an important finding since children received treatment in the morning. This finding shows that the once-daily formulation has durable effects throughout the day, Dr. Kelsey said, noting that treatment is typically given in the morning.

Dr. Kelsey added that some parent evaluations showed a separation from placebo the first day after treatment began. More typically, parents will see treatment responses within the first week of treatment.

Less than 5% of participants in each group discontinued due to adverse events. One of the common adverse effects of atomoxetine is nausea. Therefore, Dr. Kelsey suggested that physicians direct parents to give the medication with food to minimise this effect.


[Study Title: Once-Daily Atomoxetine for ADGD Including Evening and Morning Behavioral Assessment:. Abstract A25]

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