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Title: Ziprasidone Effective in Children and Adolescents with Bipolar Disorder: Presented at AACAP

"Ziprasidone Effective in Children and Adolescents with Bipolar Disorder: Presented at AACAP"

By Paula Moyer TORONTO, CANADA -- November 11, 2005 -- Children and adolescents who are experiencing the manic phase of bipolar disorder benefit from treatment with ziprasidone (Geodon), according to findings presented here at the American and Canadian Academies of Child and Adolescent Psychiatry (AACAP) annual meeting. "Ziprasidone was efficacious and well tolerated, with no statistically significant increase in body weight," said presenter Joseph Biederman, MD, during a presentation on October 21[^st.

Increasing evidence is showing that atypical neuroleptics are effective in the treatment of bipolar disorder, said Dr. Biederman, who is Chief of Pediatric Psychopharmacology, Massachusetts General Hospital, and Professor of Psychiatry, Harvard Medical School, Boston, Massachusetts, United States.

Although several agents in this class are associated with adverse metabolic effects, such as weight gain and blood lipid elevation, ziprasidone has shown minimal effects on weight, he said.

For their 8-week open-label trial Dr. Biederman and colleagues recruited 21 children and adolescents with bipolar disorder who were experiencing manic episodes. Subjects started treatment at a dosage of 1 mg/kg, which was increased by 0.5 mg/kg per week, with a maximum dose not to exceed 160 mg daily and administered twice daily.

Subjects were an average of 10.3 years old and had an average Young Mania Rating Scale (YMRS) score of 26.2 points, which is considered severe.

Among the 14 patients who completing the study 81% were male; 86% had comorbid attention deficit hyperactivity disorder, and 71% had conduct disorder.

Fourteen patients completed the treatment period. Two dropped out due to adverse events and five due to lack of efficacy.

The most frequent adverse events were sedation, headache, and gastrointestinal problems.

Dr. Biederman noted that after 1 week of treatment, the average YMRS score decreased from 26.2 points to 11 points (P < .001).

At the end of the study, 57% of subjects had at least a 30% reduction in baseline YMRS score, and 33% had at least a 50% reduction in score.

Using the Clinical Global Impressions-Improvement (CGI-I) Mania subscale, the investigators rated 57% of subjects as having improved or much improved.

Subjects gained an average of 0.6 +/- 0.4 kg in body weight, which was not statistically significant over baseline. The QTC interval did not change significantly, and decreased an average of 3.7 milliseconds.

The investigators concluded that ziprasidone is well tolerated and efficacious in the pediatric setting, and plan to investigate it further. Double-blind placebo-controlled studies are warranted on the basis of these findings, they said.

The study was funded by the Stanley Medical Research Institute. Geodon is manufactured by Pfizer.

[Presentation title: An Open-label Trial of Ziprasidone in Children and Adolescents with Bipolar Disorder. Abstract C2]

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