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Title: Atomoxetine Has Neutral Effect on Co-morbid Tics in Children With Attention Deficit/Hyperactivity Disorder: Presented at AACAP

"Atomoxetine Has Neutral Effect on Co-morbid Tics in Children With Attention Deficit/Hyperactivity Disorder: Presented at AACAP"

By Paula Moyer MIAMI BEACH, FL -- October 30, 2003 -- Children with attention deficit hyperactivity disorder (ADHD) who have co-morbid tic disorders experience no exacerbation of their tics when treated with atomoxetine (Strattera), according to findings presented here October 16th at the 50th Anniversary Meeting of the American Academy of Child & Adolescent Psychiatry. "Stimulant therapy, the mainstay treatment class for ADHD, can worsen tic symptoms," said co-investigator James T. McCracken, MD, professor of child psychiatry and director of clinical trials, University of California-Los Angeles Neuropsychiatry Institute, Los Angeles, United States. "Because as many as one-third of children with ADHD have a co-morbid tic disorder, we need to be able to improve ADHD without worsening tics." Dr. McCracken added that, although more studies would be necessary, atomoxetine might decrease tic severity. The study involved 150 children diagnosed with ADHD who also had either Tourette's syndrome or other chronic motor tics. The children were randomized to placebo or treatment with atomoxetine at a dosage range of 0.5 to 1.5 mg/kg daily for 18 weeks. As was expected, the treatment group had a greater improvement in ADHD symptoms than did the placebo group, with reductions on the ADHD Rating Scale-IV Parent Inventory total averaging 10.9 for the treatment group and 4.9 for the placebo group (P=0.002). There were also statistically significant reductions on the Inattentive and Hyperactive/Impulsive subscores (P=0.019 and P=0.002, respectively). The treatment group had a greater improvement in the Clinical Global Impressions (CGI) assessment of severity of ADHD and psychiatric symptoms, with the treatment group having a mean reduction of -0.8 while the placebo group's score on this parameter decreased by a mean of -0.3 (P=0.015). Dr. McCracken pointed out that although the 2 groups did not have statistically significant scores on the Yale Global Tic Severity Scale total scores, the treatment group had a greater numerical reduction of tic severity. The treatment group's mean decrease was 5.5, and the placebo group's mean decrease was 3.0 (P=0.063). There was a statistically significant difference in the CGI tic and neurological severity subscale, however, with the treatment group having a mean reduction of 0.7 and the placebo group having a mean reduction of 0.1 (P=0.002). As is typical with stimulant treatments, the investigators documented statistically significant elevations in heart rate and decreases in body weight in the treatment group compared to the placebo group. The treatment group had an average increase of 8.3 beats per minute, compared to a mean decrease of 1.2 beats per minute in the placebo group (P<0.001). The treatment group lost an average of 0.9 kg, and the placebo group gained an average of 1.6 kg (P<0.001). Although the atomoxetine group had higher rates of decreased appetite and nausea than did the placebo group, the investigators documented no other clinically relevant differences regarding safety parameters. [Study Title: Improvement of ADHD By Atomoxetine in Children with Tic Disorders. Abstract A35]

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