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.
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: Barbara Geller; Joan L Luby; Paramjit Joshi; Karen Dineen Wagner; Graham Emslie; John T Walkup; David A Axelson; Kristine Bolhofner; Adelaide Robb; Dwight V Wolf; Mark A Riddle; Boris Birmaher; Nasima Nusrat; Neal D Ryan; Benedetto Vitiello; Rebecca Tillman; Philip Lavori Journal: Arch Gen Psychiatry Date: 2012-01-02
Authors: Gagan Joshi; Carter Petty; Janet Wozniak; Stephen V Faraone; Robert Doyle; Anna Georgiopoulos; Paul Hammerness; Sarah Walls; Breanna Glaeser; Kristin Brethel; Dayna Yorks; Joseph Biederman Journal: J Affect Disord Date: 2011-10-28 Impact factor: 4.839
Authors: Joseph Biederman; Carter R Petty; K Yvonne Woodworth; Alexandra Lomedico; Katherine B O'Connor; Janet Wozniak; Stephen V Faraone Journal: J Clin Psychiatry Date: 2011-11-01 Impact factor: 4.384
Authors: Cesar A Soutullo; Melissa P DelBello; Jennifer E Ochsner; Susan L McElroy; Siobhan A Taylor; Stephen M Strakowski; Paul E Keck Journal: J Affect Disord Date: 2002-08 Impact factor: 4.839
Authors: Benedetto Vitiello; Mark A Riddle; Gayane Yenokyan; David A Axelson; Karen D Wagner; Paramjit Joshi; John T Walkup; Joan Luby; Boris Birmaher; Neal D Ryan; Graham Emslie; Adelaide Robb; Rebecca Tillman Journal: J Am Acad Child Adolesc Psychiatry Date: 2012-07-31 Impact factor: 8.829