Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder
Status:
Terminated
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the
treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or
Bipolar Spectrum Disorder. Specific hypotheses are as follows:
Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar
I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.
Hypothesis 2: Invega -associated improvement in bipolar disorder symptomatology in children
and adolescents will translate into improved functional capacities (neuropsychological,
social, and occupational), as well as an increased quality of life throughout treatment.
Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out
rate and absence of major side effects.