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CompletedNCT02456454

Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Nationwide Children's Hospital · Academic / Other
Sex
All
Age
3 Years – 7 Years
Healthy volunteers
Not accepted

Summary

Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.

Detailed description

The objective of this study was to study the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.

Conditions

Interventions

TypeNameDescription
DRUGRisperidoneLiquid risperidone
DRUGValproic AcidLiquid valproic acid
DRUGPlacebo

Timeline

Start date
2006-01-01
Primary completion
2010-06-01
Completion
2010-06-01
First posted
2015-05-28
Last updated
2018-12-12

Source: ClinicalTrials.gov record NCT02456454. Inclusion in this directory is not an endorsement.

Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder (NCT02456454) · Clinical Trials Directory