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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborator: Stanley Medical Research Institute
• Treatments: Risperidone; Valproic Acid

Criteria

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.