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

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

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.

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.

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.