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

NCT02456454 | Completed Phase 3

• 1 other identifier: CHMC#03-12-26
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale

  Young Mania Rating Scale

  6 weeks

Secondary Outcomes (1)

• Clinical Global Improvement Scale

  6 weeks

Study Arms (3)

Risperidone

EXPERIMENTAL

Risperidone, PO 0.25-2 mg/day

Drug: Risperidone

Valproic

EXPERIMENTAL

Valproic Acid PO to achieve plasma levels of 85-100

Drug: Valproic Acid

Placebo

PLACEBO COMPARATOR

Liquid placebo PO matched for color and taste.

Drug: Placebo

Interventions

Risperidone DRUG

Liquid risperidone

Also known as: Risperdal

Risperidone

Valproic Acid DRUG

Liquid valproic acid

Also known as: Valproate

Valproic

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects were male or female outpatient subjects,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Stanley Medical Research Institute: collaborator

Related Publications (1)

• 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.

  PMID: 25978742 RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Risperidone; Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Robert A Kowatch, MD, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 28, 2015
• Study Start: January 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share