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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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