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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02456454

Enrollment

Registered

2015-05-28

Start date

2006-01-31

Completion date

2010-06-30

Last updated

2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Brief 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.

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.

Interventions

DRUGRisperidone

Liquid risperidone

DRUGValproic Acid

Liquid valproic acid

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 7 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Young Mania Rating Scale	6 weeks	Young Mania Rating Scale

Secondary

Measure	Time frame	Description
Clinical Global Improvement Scale	6 weeks	Clinical Global Improvement Scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026