A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder.

Abstract

OBJECTIVE:

To assess the effectiveness and tolerability of ziprasidone for treating pediatric mania.

METHODS:

This was an eight-week, open-label, prospective study of ziprasidone monotherapy (57.3 +/- 33.9 mg/day) in 21 bipolar youth [manic, mixed, or bipolar not otherwise specified (NOS); 6-17 years old]. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs, weight monitoring, and laboratory analysis.

RESULTS:

Fourteen of the 21 youth (67%) completed the study. Ziprasidone treatment was associated with clinically and statistically significant improvement in mean YMRS scores (-10.8 +/- 8.4, p < 0.0001) and 57% had a CGI-I <or=2 at endpoint. Ziprasidone was well tolerated with no statistically significant increase in body weight (0.6 +/- 0.4 kg, p = 0.2) or QTc interval (-3.7 +/- 4.7, p = 0.5).

CONCLUSIONS:

Open-label ziprasidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder. Future placebo-controlled, double-blind studies are warranted.

• Authors: Joseph Biederman, Eric Mick, Thomas Spencer, Meghan Dougherty, Megan Aleardi, Janet Wozniak
• Journal: Bipolar disorders (Bipolar Disord) Vol. 9 Issue 8 Pg. 888-94 (Dec 2007) ISSN: 1398-5647 [Print] Denmark
• PMID: 18076539 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Piperazines
• Thiazoles
• ziprasidone

Topics

• Antipsychotic Agents (therapeutic use)
• Bipolar Disorder (drug therapy)
• Body Weight (drug effects)
• Evaluation Studies as Topic
• Female
• Humans
• Male
• Pediatrics
• Piperazines (therapeutic use)
• Prospective Studies
• Psychiatric Status Rating Scales
• Severity of Illness Index
• Thiazoles (therapeutic use)