Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Information source: Nationwide Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Risperidone (Drug); Valproic Acid (Drug); Placebo Valproic Acid (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Nationwide Children's Hospital Official(s) and/or principal investigator(s):
Robert A Kowatch, MD, PhD, Principal Investigator, Affiliation: Nationwide Children's Hospital
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.
Clinical Details
Official title: Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Young Mania Rating Scale
Secondary outcome: Clinical Global Improvement Scale
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.
Eligibility
Minimum age: 3 Years.
Maximum age: 7 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: January 2006
Last updated: May 26, 2015
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