CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 65 enrolled
Drug / intervention
Divalproex Sodium +1 moredrug
Likely dose
Divalproex sodium and risperidone (doses not specified in published record)AI-extracted
Key inclusion· 2
  • ✓Diagnosis of Bipolar Disorder
  • ✓Ability to swallow tablets
Key exclusion· 4
  • ✕General medical conditions such as head injury, epilepsy, or endocrine disorders
  • ✕Concurrent mood-altering medications such as steroids
  • ✕Intellectual disability (mental retardation)
  • ✕Inability of parent and/or child to understand consent/assent procedures

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00176202
NCT00176202Phase 3Completed
CompareCT.gov

Controlled Trial of Risperidone and Divalproex Sodium With MRI Assessment of Affected Circuitry in Pre and Post Treatment in Pediatric Bipolar

University of Illinois at Chicago·interventional·Posted Sep 15, 2005·Updated Nov 5, 2015

In Brief

A Phase 3 clinical trial evaluating Divalproex Sodium and risperidone for Bipolar Disorder. Completed, enrolled 65 participants across 3 sites.

Detailed Summary

The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartApr 1, 2003
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.8 years ago

Interventions

Divalproex Sodiumdrug

Divalproex sodium is a mood stabilizer

risperidonedrug

Risperidone is a second generation antipsychotic and antimanic drug