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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

Page last updated: August 23, 2015

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