At a glance
ClinicalIndex Comparison Record- ✓Male or female patients aged 3 years to 7 years 11 months.
- ✓DSM-IV diagnosis of Bipolar I Disorder (manic, mixed, or single manic episode) or Bipolar II Disorder (most recent episode hypomanic).
- ✓YMRS total score ≥20 at baseline (day 0).
- ✕Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
- ✕Neurologic disorders including epilepsy, stroke, or severe head trauma.
- ✕Mental retardation (IQ <70), evidence of Fetal Alcohol Syndrome or Alcohol-Related Neurodevelopmental Disorder.
- ✕History of hypersensitivity to or intolerance of risperidone or valproate.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
In Brief
A Phase 3 clinical trial evaluating Risperidone oral solution, Valproate Oral Solution, and 1 other intervention for Bipolar Disorder. Completed, enrolled 46 participants across 2 sites.
Detailed Summary
The primary aim of this proposal is to conduct a preliminary controlled trial of valproate and risperidone in children ages 3-7 yr. with bipolar disorders. A secondary aim is to carefully characterize these subjects using clinical rating scales and develop pilot data on a very young cohort of children with bipolar disorders that can be used to support an application to NIMH for a prospective, longitudinal study that will provide important information about the course, medication response, neurobiology and outcome of these patients.
Study Details
Timeline
Interventions
liquid, BID dosing.
liquid, BID dosing.
liquid, BID dosing.