Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder
| Status: | Archived |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2007 |
| End Date: | May 2012 |
Open-Label Study of Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder
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.
Invega (paliperidone), a second generation antipsychotic (SGA), is a psychotropic agent
belonging to the chemical class of benzisoxazole derivatives. Invega is approved by the FDA
for the treatment of schizophrenia in adults. Initial data suggest a promising role for
Invega in the treatment of bipolar disorder with minimal adverse events of weight gain. We
propose to study the safety and efficacy of Invega therapy in children and adolescents with
Bipolar I, Bipolar II, and Bipolar Spectrum Disorder. The study results will be used to
generate hypotheses for a larger, randomized, controlled clinical trial with explicit
hypotheses and sufficient statistical power.
The proposed study includes 1) use of a 8-week design to document the response rate, 2)
assessment of the impact of Invega on functional capacities (quality of life, psychosocial
function) and cognition, and 3) careful assessment of safety and tolerability.
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