1. A prospective open-label trial of paliperidone monotherapy for the treatment of bipolar spectrum disorders in children and adolescents
- Author
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K. Yvonne Woodworth, Gagan Joshi, Stephen V. Faraone, Janet Wozniak, Rachel Shelley-Abrahamson, Joseph Biederman, Carter R. Petty, Hannah McKillop, Stephannie L. Furtak, and Andrea E. Spencer
- Subjects
Male ,Pediatrics ,medicine.medical_specialty ,Bipolar Disorder ,Adolescent ,Pilot Projects ,Young Mania Rating Scale ,Surveys and Questionnaires ,Paliperidone Palmitate ,Brief Psychiatric Rating Scale ,medicine ,Humans ,Paliperidone ,Prospective Studies ,Bipolar disorder ,Child ,Psychiatric Status Rating Scales ,Pharmacology ,business.industry ,Isoxazoles ,medicine.disease ,Pyrimidines ,Treatment Outcome ,Tolerability ,Clinical Global Impression ,Female ,medicine.symptom ,business ,Mania ,Antipsychotic Agents ,medicine.drug - Abstract
Treatment studies for the management of pediatric bipolar disorder are limited. 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. 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. 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
- Published
- 2013
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