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Objectives: Lack of response to treatment and side effects of antipsychotics limit their use in early onset psychosis and mood disorders. Ziprasidone has been recently approved by the U.S. Food and Drug Administration for children with bipolar disorder (BD) above 10 years of age as a third line strategy. There are only few studies for ziprasidone use in early onset psychiatric disorders. The primary objective of this study was to evaluate the effectiveness and tolerability of ziprasidone in children and adolescents hospitalized in a psychiatric inpatient unit.
Method: A retrospective chart review was conducted on children and adolescents, who received ziprasidone in the inpatient psychiatry unit of Bakirkoy Research & Training Hospital for Psychiatry, Neurology and Neurosurgery, between 1 January 2006, and 31 December 2013, Medical charts of 27 adolescents were reviewed to determine clinical information, tolerability and effectiveness of ziprasidone. Patients were evaluated according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision based on clinical assessment. Severity of symptoms and clinical response of were assessed with Young Mania Rating Scale (YMRS) for BD and Negative Syndrome Scale (PANNS) for psychosis. The PANNS and YMRS scores and electrocardiogram were obtained at baseline and then weekly. Side effects were also obtained.
Results: Parents of 2 of 27 patients discharged their children before their treatment was completed. Forty percent of the 25 patients were female. The mean age was 16 years and 2 months with a standard deviation of 15 months (range 13 years-17 years and 8 months). The psychiatric diagnoses were BD (32%, n=8), psychosis (32%, n=8), conduct disorder (20%, n=5), Obsessive compulsive disorder (8%, n=2), tic disorder (4%, n=1) and autism (4%, n=1). Generally, ziprasidone was either added to the existing antipsychotic treatment or other antipsychotics were replaced with ziprasidone; only 16% of the patients were treatment-naïve. Previously used antipsychotics were replaced with ziprasidone due to the ineffectiveness in 72% of (n=18) patients and side effects in 12% (n=3) of patients. Mean initial dose of ziprasidone was 55.20 (range 40-80) mg/day and mean maximum dose of ziprasidone was 136.80 (range 40-240) mg/day. Four patients reported side effects, including prolactinemia and asymptomatic QTc prolongation. None of the patients developed severe complications including arrhythmia. Improvement was recorded in 37.5% of patients with psychosis and 62.5% of patients with BD; with a total number of 14 patients (56%).
Conclusions: Evidence from this study supports the effectiveness and safety of ziprasidone for a variety of psychiatric disorders in children and adolescents. Ziprasidone can be considered as a viable treatment option for patients, who do not respond or experience side effects with other antipsychotics. Ziprasidone was generally well tolerated, with asymptomatic QTc prolongation as the most common side effect for discontinuation. Long-term follow-up studies may provide further knowledge about the safety of ziprasidone in this age group.