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A prospective open-label trial of paliperidone monotherapy for the treatment of bipolar spectrum disorders in children and adolescents
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A prospective open-label trial of paliperidone monotherapy for the treatment of bipolar spectrum disorders in children and adolescents
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A prospective open-label trial of paliperidone monotherapy for the treatment of bipolar spectrum disorders in children and adolescents
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Journal Article
A prospective open-label trial of paliperidone monotherapy for the treatment of bipolar spectrum disorders in children and adolescents
2013
Overview
Rationale
Treatment studies for the management of pediatric bipolar disorder are limited.
Objectives
This study evaluates the safety and efficacy of paliperidone monotherapy as an acute treatment of mania and related symptoms in youth with bipolar spectrum disorders.
Methods
An 8-week, prospective, open-label paliperidone monotherapy trial to assess effectiveness and tolerability in treating pediatric bipolar spectrum and related disorders (depression, psychosis, attention-deficit/hyperactivity disorder [ADHD]). Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impression scale (CGI), Children’s Depression Rating Scale-Revised (CDRS-R), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs, weight monitoring, and laboratory analysis.
Results
Fifteen youth with bipolar spectrum disorders (YMRS at entry: 32.8 ± 6.1) were enrolled in the study and 11 (73 %) completed the 8-week trial. The total daily dose of paliperidone at study endpoint was 3 mg in 12 subjects and 6 mg in three subjects. Treatment with paliperidone was associated with statistically significant levels of improvement in mean YMRS scores (−18.7 ± 13.9,
p
< 0.001) at endpoint. Paliperidone treatment also resulted in significant improvement in the severity of ADHD and psychotic symptoms. Although treatment with paliperidone was generally well tolerated and was not associated with clinically significant change in cardiovascular or metabolic parameters, increases in body weight (4.1 ± 5.5 lb) were substantial.
Conclusions
Open-label paliperidone treatment appears to be beneficial in the treatment of bipolar spectrum disorders and associated conditions in youth. Future placebo-controlled studies are warranted to confirm these findings.
Publisher
Springer-Verlag,Springer,Springer Nature B.V
Subject
/ Antipsychotic Agents - administration & dosage
/ Antipsychotic Agents - adverse effects
/ Antipsychotic Agents - therapeutic use
/ Biomedical and Life Sciences
/ Bipolar Disorder - drug therapy
/ Bipolar Disorder - psychology
/ Child
/ Female
/ Humans
/ Isoxazoles - administration & dosage
/ Isoxazoles - adverse effects
/ Isoxazoles - therapeutic use
/ Male
/ Psychiatric Status Rating Scales
/ Pyrimidines - administration & dosage
/ Pyrimidines - adverse effects
