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Atomoxetine Provides Pronounced Benefits in Patients with Oppositional Defiant Disorder: Presented at CINP

By Jill Stein

PARIS, FRANCE -- June 22, 2004 -- Atomoxetine helps prevent relapses in patients with attention-deficit/hyperactivity disorder (ADHD), especially those with coexisting oppositional defiant disorder (ODD), according to data presented here on June 22nd at the XXIV Collegium Internationale Neuro-psychopharmacologicum Congress.

Atomoxetine is a selective norepinephrine reuptake inhibitor with little or no affinity for other neuronal transporters or neurotransmitter receptor sites.

The new results are from a study that compared the efficacy of atomoxetine and placebo in preventing relapse among a subgroup of 415 patients with ADHD and ODD 9 months after an initial 3 months of open-label treatment.

"The co-occurrence of ADHD and ODD is one of the most common comorbid associations seen in child and adolescent psychiatry," Philip Hazell, MD, Professor of Psychiatry, University of Newcastle, and Director, Child and Mental Health Service, New South Wales, Australia. Comorbidity is clinically relevant as it may alter the response to treatment, usually rendering treatment less effective.

To date, however, no study has demonstrated that ODD influences the response of children with ADHD who are treated with atomoxetine for 9 months.

In the present analysis, patients were 6 to 15 years of age and were diagnosed with ADHD according to criteria set out in the Diagnostic and Statistical Manual – Revision IV. Their symptoms remitted during the initial 12 weeks of atomoxetine treatment.

Patients were randomized to 9 months of double-blind continuation therapy with atomoxetine or placebo substitution. Forty 2% of atomoxetine-treated patients and 45% of placebo-treated patients also had ODD.

Overall, 22.3% of patients assigned to atomoxetine had symptom relapses compared with 37.9% of placebo patients (P =.002). Patients with ODD had greater protective effect from atomoxetine than patients without ODD (P =.037). The difference in mean time to relapse between the drug-treated groups and placebo-treated groups was similar for patients with or without co-morbid ODD.

Among patients treated with atomoxetine, 17% of 123 patients with ODD relapsed versus 26% of 168 patients without ODD (RR = .67). For patients without ODD, the relapse rates were 25.6% for atomoxetine and 33.8% for placebo.

Dr. Hazell cautioned that the results are limited by the fact that the study did not include teacher-reported measures of outcome. Also, the study was post hoc in nature and was not designed to specifically assess ODD outcomes.

"Owing to the requirement that patients meet efficacy criteria during a 10-week open-label trial prior to randomization, it is possible that more severely affected and treatment resistant children with comorbid ODD were excluded from the study, thus biasing the result," he said.

"While the findings from the present study must be considered preliminary, the data suggest that atomoxetine is effective in patients with ADHD and comorbid ODD, and it may be this subgroup of patients that is particularly well protected against relapse over the medium term," he noted. "As nearly half of patients presenting for the treatment of ADHD have comorbid ODD, this is an important observation."

The study was sponsored by Lilly Research Laboratories, Indianapolis, Indiana.


[Presentation title: "Effect of Oppositional Defiant Disorder on Risk of ADHD Relapse During Treatment With Atomoxetine." Abstract P01.531]

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