Abstract
Quetiapine is a second-generation antipsychotic (SGA) approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia, mania, and aggression in children and adolescents. It is also commonly used as an off-label medication to treat children and adolescents with bipolar depression, although the FDA has not approved quetiapine for this purpose. We conducted a systematic review of randomized clinical trials (RCTs) using the MEDLINE database and included two studies that met our inclusion criteria. Both RCTs were eight-week short-term studies that involved patients of 10-18 years of age with a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of bipolar disorder, depressed type. The mean difference in the Children's Depression Rating Scale-Revised (CDRS-R) score and the response and remission rates in the quetiapine group were not statistically significant when compared to the placebo group. A high placebo response rate proved that quetiapine was no better than the placebo in treating pediatric bipolar depression. Quetiapine proved to be a relatively safe drug with the most common side effects being headache, somnolence, gastric upset, and weight gain. There was a significant increase in triglyceride levels, but no other metabolic effects were reported. This calls for future studies with larger sample sizes and improved methodology to explore the efficacy of quetiapine and other SGAs for the management of pediatric bipolar depression.
Highlights
BackgroundBipolar disorder is characterized by mood dysregulation ranging from hypomania or mania to depression, along with unusual shifts in energy, activity levels, concentration, and the ability to carry out daily activities [1]
This calls for future studies with larger sample sizes and improved methodology to explore the efficacy of quetiapine and other second-generation antipsychotic (SGA) for the management of pediatric bipolar depression
Quetiapine is Food and Drug Administration (FDA)-approved for treating manic episodes of bipolar disorder in the pediatric population (1017 years of age) with a dose range of 400-800 mg/day
Summary
Bipolar disorder is characterized by mood dysregulation ranging from hypomania or mania to depression, along with unusual shifts in energy, activity levels, concentration, and the ability to carry out daily activities [1]. The main drawback of DelBello et al.'s DBPC-RCT was its small sample size, which limited the power of the study along with a high placebo response rate This proved that quetiapine was not significantly efficacious than the placebo in reducing depressive symptoms [9]. The study by Findling et al found a high placebo response rate of 55% despite an increase in sample size Both the DBPC-RCTs found that the difference in CDRS-R score and the response and remission rates in the quetiapine group was not statistically significant when compared to the placebo group, concluding that quetiapine was no more effective than the placebo in improving the depressive symptoms in children and adolescents with bipolar depression [8,9]. No patients in the quetiapine group had suicidal ideation or attempts during the study period [8,9]
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