1.2. Pediatrics

Quetiapine is FDA-approved for acute mania in bipolar disorder in pediatric patients 10-17 years of age, and acute management of schizophrenia in adolescents 13-17 years. Pediatric quetiapine dosages are summarized in Table 3. An additional column reflecting literature-based dosing included in the Texas Health and Human Services Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version) is included in Table 3.

Legend:

• BD = bipolar I disorder
• ER = extended-release
• IR = immediate-release 

Currently there is no FDA-approved indication for low-dose quetiapine use (150 mg/day or less) in the pediatric population. Data have been published that address quetiapine safety and efficacy for the treatment of various conditions in the pediatric population, and some of the patients included were taking quetiapine doses of 150 mg/day or less. Summary details of these publications can be found in Table 4.

Evidence suggests that quetiapine use in children for a variety of indications including conduct disorder, attention-deficit/hyperactivity disorder, bipolar disorder, and other psychoses may be beneficial as monotherapy in some situations and as combination therapy in others. Although most trials used a mean dose greater than 300 mg/day, all studies presented in Table 4 utilized quetiapine doses of 150 mg/day or less. Based on the trials collectively, using quetiapine in patients younger than 18 years of age resulted in significantly improved scores on many of the psychiatric evaluations. Although average doses in the trials exceeded 150 mg/day, efficacy did not seem to be limited to higher quetiapine doses.29-39 However, many of these trials had several limitations that are important to consider. All trials were open-label trials, included very small numbers of participants, and were relatively short in duration. Only one trial was randomized, and most did not have a comparator or control group. ^35-38

While efficacy results seem promising from these trials, there are important adverse effects associated with quetiapine use in children. Weight gain, other metabolic changes, and sedation/somnolence, well known adverse effects associated with quetiapine use, were frequently reported by trial participants ^35-38. Moreno et al.40 published a trial examining the metabolic effects of quetiapine and other SGA medications on children being treated for bipolar disorder as well as other psychotic and nonpsychotic disorders. This study found that after three months of treatment with an SGA, over 70% of patients experienced abnormal weight gain. Due to the frequency of weight gain and sedation occurring with SGA use, Penzner et al.41 studied the effect of co-prescribing a stimulant, which can cause weight loss and insomnia, to neutralize the adverse effects of the antipsychotic. Investigators found no significant differences in body composition and metabolic profiles between SGA-treated patients managed concurrently with or without stimulants.

Low-dose quetiapine treatment for children with various psychotic or behavioral disorders has been beneficial in some cases. However, possible adverse events that may negatively impact health and quality of life need to be considered before treatment initiation.