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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456454
• Other study ID #: CHMC#03-12-26
• Status: Completed
• Phase: Phase 3
• Start date: January 2006
• Est. completion date: June 2010

Study information

• Verified date: December 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria

• Subjects were male or female outpatient subjects,

• 3.0 - 7 years 11 months of age

• Bipolar I or II Disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to DSM IV criteria (American Psychiatric Association 1994)

• with a score > 20 on the Young Mania Rating Scale (YMRS.

Exclusion Criteria

• clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions;

• neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests:

• CBC with differential,

• electrolytes,

• BUN,

• creatinine,

• hepatic transaminases,

• urinalysis,

• thyroid indices (T3, Total T4, Free T4, TSH) and

• EKG

• mania due to a general medical condition or substance-induced mania

• mental retardation (IQ <70),

• evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder,

• Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Drug:
• Risperidone
Liquid risperidone
• Valproic Acid
Liquid valproic acid
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Stanley Medical Research Institute

References & Publications (1)

Kowatch RA, Scheffer RE, Monroe E, Delgado S, Altaye M, Lagory D. Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):306-13. doi: 10.1089/cap.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Young Mania Rating Scale	Young Mania Rating Scale	6 weeks
Secondary	Clinical Global Improvement Scale	Clinical Global Improvement Scale	6 weeks