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

Nationwide Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Valproic Acid; Drug: Placebo; Drug: Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT02456454

CHMC#03-12-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 3 patient groups, including a placebo group

Risperidone

Experimental group

Description:

Risperidone, PO 0.25-2 mg/day

Treatment:

Drug: Risperidone

Valproic

Experimental group

Description:

Valproic Acid PO to achieve plasma levels of 85-100

Treatment:

Drug: Valproic Acid

Placebo

Placebo Comparator group

Description:

Liquid placebo PO matched for color and taste.

Treatment:

Drug: Placebo