SAN DIEGO – Atomoxetine is effective and well tolerated in children and adolescents with attention-deficit hyperactivity disorder and a coexisting anxiety disorder, results from a randomized, placebo-controlled trial show.
“If you have kids who have anxiety disorders with their ADHD, you want to consider atomoxetine as a treatment intervention,” Dr. Daniel Geller said in an interview during a poster session at the annual meeting of the American Academy of Child and Adolescent Psychiatry. “There are other ways of managing them, including using an SSRI with a stimulant, [but] there's a concern in using stimulants in kids who have both ADHD and anxiety. There's always a concern that their anxiety will be exacerbated or triggered.”
A nonstimulant, atomoxetine (Strattera, Eli Lilly and Co.) is approved for ADHD treatment in children, adolescents, and adults, but it is not approved for treating anxiety disorders.
In a multicenter study, Dr. Geller and his associates randomized 176 patients aged 8–17 years who met DSM-IV criteria for ADHD and anxiety disorder to receive 12 weeks of atomoxetine treatment or placebo.
The researchers then used a battery of tests to compare the two groups, including the Multidimensional Anxiety Scale for Children (MASC), the Life Participation Scale for ADHD-Revised (LPS-ADHD-R), the Child Health Questionnaire-Parent-Completed Full-Length psychosocial summary score (CHQ-PF50), and the Clinical Global Impressions, Severity of Illness scale (CGI-S).
The mean age of the patients was 12 years, and 65% were boys, reported Dr. Geller of Massachusetts General Hospital's pediatric psychopharmacology research program in Cambridge, Mass.
Of the 176 patients, 87 received atomoxetine while 89 received placebo. The target dose of atomoxetine was 1.2 mg/kg per day, but that dose could be increased to 1.8 mg/kg per day for those who did not respond to the target dose, Dr. Geller said.
Of the 176 patients, 66 in each group completed all 12 weeks of the study. Dr. Geller reported that mean scores improved significantly for patients in the atomoxetine treatment group, compared with the placebo group, on the MASC (−4.6 vs. 2.1, respectively), the LPS-ADHD-R (9.5 vs. 3.1), the CHQ-PF50 (6.9 vs. 3.3), and the CGI-S (−0.9 vs. −0.4).
The only adverse event to occur significantly more often in the atomoxetine group than the placebo group was decreased appetite (14% vs. 4%, respectively).
Other adverse events that were relatively common but not significant between the two groups were headache (14% in the atomoxetine group vs. 9% in the placebo group) and upper abdominal pain (12% vs. 5%).
The study was funded by Lilly Research Laboratories.