Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder

Pediatric Bipolar Disorder Clinical Trial

Official title: 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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Pediatric Bipolar Disorder

• NCT number: NCT00592358
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Terminated
• Phase: Phase 4
• Start date: November 2007
• Completion date: December 2009