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

NCT ID: NCT02456454

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-06-30

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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Risperidone

Risperidone, PO 0.25-2 mg/day

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

Liquid risperidone

Valproic

Valproic Acid PO to achieve plasma levels of 85-100

Group Type EXPERIMENTAL

Valproic Acid

Intervention Type DRUG

Liquid valproic acid

Placebo

Liquid placebo PO matched for color and taste.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Risperidone

Liquid risperidone

Intervention Type DRUG

Valproic Acid

Liquid valproic acid

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Risperdal Valproate

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Robert Kowatch

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert A Kowatch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

References

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Kowatch RA, Scheffer RE, Monroe E, Delgado S, Altaye M, Lagory D. Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):306-13. doi: 10.1089/cap.2014.0166.

Reference Type RESULT
PMID: 25978742 (View on PubMed)

Other Identifiers

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CHMC#03-12-26

Identifier Type: -

Identifier Source: org_study_id