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Trial record 97 of 533 for:    Taste Disorders

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

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ClinicalTrials.gov Identifier: NCT02456454
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Robert Kowatch, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Risperidone Drug: Valproic Acid Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Study Start Date : January 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Risperidone
Risperidone, PO 0.25-2 mg/day
Drug: Risperidone
Liquid risperidone
Other Name: Risperdal

Experimental: Valproic
Valproic Acid PO to achieve plasma levels of 85-100
Drug: Valproic Acid
Liquid valproic acid
Other Name: Valproate

Placebo Comparator: Placebo
Liquid placebo PO matched for color and taste.
Drug: Placebo



Primary Outcome Measures :
  1. Young Mania Rating Scale [ Time Frame: 6 weeks ]
    Young Mania Rating Scale


Secondary Outcome Measures :
  1. Clinical Global Improvement Scale [ Time Frame: 6 weeks ]
    Clinical Global Improvement Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456454


Sponsors and Collaborators
Nationwide Children's Hospital
Stanley Medical Research Institute
Investigators
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Principal Investigator: Robert A Kowatch, MD, PhD Nationwide Children's Hospital

Publications of Results:
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Responsible Party: Robert Kowatch, MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02456454     History of Changes
Other Study ID Numbers: CHMC#03-12-26
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Pathologic Processes
Risperidone
Valproic Acid
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents