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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Risperidone
* Drug: Valproic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risperidone<br>Risperidone, PO 0.25-2 mg/day | Drug: Risperidone<br>* Liquid risperidone<br>* Other names: Risperdal;|
| Experimental: Valproic<br>Valproic Acid PO to achieve plasma levels of 85-100 | Drug: Valproic Acid<br>* Liquid valproic acid<br>* Other names: Valproate;|
| Placebo Comparator: Placebo<br>Liquid placebo PO matched for color and taste. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Mania Rating Scale | Young Mania Rating Scale | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Improvement Scale | Clinical Global Improvement Scale | 6 weeks |