ISTANBUL, TURKEY – Flexibly dosed ziprasidone displayed favorable safety and efficacy in children and adolescents with bipolar I disorder in a double-blind, placebo-controlled, randomized clinical trial.
The study involved 238 bipolar I patients aged 6–17 years with a manic or mixed episode who were randomized 2:1 to ziprasidone (Geodon) at 60–160 mg/day or placebo at 36 U.S. centers. Sixty-five percent of patients in the ziprasidone arm and 58% assigned to placebo completed the 4-week trial, Dr. Robert L. Findling reported at the annual congress of the European College of Neuropsychopharmacology.
The primary study end point was change in the Young Mania Rating Scale total score over the course of 4 weeks. The ziprasidone group had a mean 13.8-point drop, significantly greater than the 8.6-point decrease with placebo, according to Dr. Findling, professor of psychiatry and pediatrics at Case Western Reserve University, Cleveland.
The secondary end point was change over time in the Clinical Global Impression of Severity score: a mean reduction of 1.43 points from baseline in the ziprasidone group, compared with a 0.74-point decrease in controls.
The efficacy curves began separating within the first week, while ziprasidone was still being titrated toward a target dose of 60–80 mg/day in children weighing less than 45 kg, or 120–160 mg in those weighing more. The second-generation antipsychotic was given twice daily with food.
Side effects of ziprasidone were similar to those encountered in adult therapy. Sedation occurred in one-third of patients; somnolence in one-quarter; and nausea, fatigue, and dizziness each in 11%–13% of patients.
Weight gain occurred in one patient in each study arm. Prolongation of the QT interval on ECG was noted in a single patient in the ziprasidone arm, whose peak was 478 milliseconds (msec). The mean increase in QT interval in the ziprasidone group at 4 weeks was 8.3 msec, compared with a mean 2.9 msec decrease in the placebo arm.
This is an important study because of the limited safety and efficacy data available on the use of antipsychotic agents among pediatric patients, along with the documented importance of initiating treatment as early in the disease course as possible to achieve the best possible outcomes, according to the psychiatrist.
The trial was supported by Pfizer Inc., manufacturer of ziprasidone. Dr. Findling disclosed having received research grants and/or serving as a consultant to or on the speakers bureau for Pfizer and roughly a dozen other pharmaceutical companies.
With ziprasidone, the mean drop in the score was 13.8 points, compared with 8.6 in the placebo group.
Source DR. FINDLING