A prospective open-label trial of paliperidone monotherapy for the treatment of bipolar spectrum disorders in children and adolescents.

Abstract

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.

• Authors: Gagan Joshi, Carter Petty, Janet Wozniak, Stephen V Faraone, Andrea E Spencer, K Yvonne Woodworth, Rachel Shelley-Abrahamson, Hannah McKillop, Stephannie L Furtak, Joseph Biederman
• Journal: Psychopharmacology (Psychopharmacology (Berl)) Vol. 227 Issue 3 Pg. 449-58 (Jun 2013) ISSN: 1432-2072 [Electronic] Germany
• PMID: 23397049 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Isoxazoles
• Pyrimidines
• Paliperidone Palmitate

Topics

• Adolescent
• Antipsychotic Agents (administration & dosage, adverse effects, therapeutic use)
• Bipolar Disorder (drug therapy, psychology)
• Child
• Female
• Humans
• Isoxazoles (administration & dosage, adverse effects, therapeutic use)
• Male
• Paliperidone Palmitate
• Pilot Projects
• Prospective Studies
• Psychiatric Status Rating Scales
• Pyrimidines (administration & dosage, adverse effects, therapeutic use)
• Surveys and Questionnaires
• Treatment Outcome