Source: DGNews  |  Posted 3 years ago

By Laura Gater

CHICAGO -- November 6, 2008 -- Quetiapine therapy appears to increase the level of function of children and adolescents with bipolar I disorder and in adolescents with schizophrenia and reduces caregiver burden, researchers reported here at the American Academy of Child and Adolescent Psychiatry (AACAP) 55th Annual Meeting.

Two previous multicentre, placebo-controlled, short-term trials demonstrated the efficacy of quetiapine for mania in children and adolescents with bipolar I disorder and for psychotic symptoms in adolescents with schizophrenia, noted investigator Melissa P. DelBello, MD, University of Cincinnati College of Medicine, Cincinnati, Ohio.

To determine the long-term effects of quetiapine for mania and psychotic symptoms, Dr. DelBello and colleagues conducted an open-label, 26-week extension in children and adolescents who participated in these 2 studies.

Study subjects were aged 10 to 18 years in the bipolar I population and aged 13 to 18 years in the schizophrenia population.

The researchers assessed adverse events, vital signs, laboratory test results, and movement disorder rating scales from enrolment in the open-label phase to week 26 as well as growth, pubertal development, and level of functioning.

All 380 patients received treatment with open-label quetiapine at 50 mg on day 1, 100 mg on day 2, 300 mg on day 4, and 400 mg by day 5. The dose was then maintained or increased to a maximum of 800 mg/day at the investigator's discretion, with the option of reducing it to 200 mg/day depending on tolerability.

A total of 237 patients (62%) completed the 26-week extension. The mean length of study participation was 156 days.

The mean quetiapine dose was 500 mg/day in the overall group, 571 mg/day in the bipolar I group, and 632 mg/day in the schizophrenia group.

"Generally, baseline disease characteristics were milder in patients previously treated with quetiapine compared with those previously treated with placebo," said Dr. DelBello.

The overall incidence of adverse events was 84.5%: 89.8% in patients with bipolar I disorder and 78.3% in those with schizophrenia. Serious adverse events occurred in 11.3% of the overall group: exacerbation of bipolar disorder (2.9%), schizophrenia (1.8%), and aggression (0.8%) were most common.

Discontinuation of treatment due to adverse events was seen in 9.7% of all patients. Changes in vital signs and electrocardiographic parameters over the course of treatment were small.

Efficacy was maintained for all variables after 26 weeks of open-label treatment with quetiapine, Dr. DelBello said.

Patients who were previously treated with placebo during the acute studies and treated with quetiapine in the extension study showed the greatest changes from baseline in efficacy variables.

The researchers concluded that quetiapine was generally well tolerated in both children and adolescents with bipolar I disorder and in adolescents with schizophrenia. Quetiapine was associated with an increased level of function and reduced caregiver burden. Efficacy measures continued to improve numerically during open-label treatment with quetiapine for up to 26 weeks.

[Presentation title: Safety and Tolerability of Quetiapine in Children and Adolescents With Bipolar I Disorder and Adolescents With Schizophrenia: a 26-Week, Open-Label Study. Abstract 3.24]