Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00221403
First received: September 14, 2005
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

The primary aim of this proposal is to conduct a preliminary controlled trial of valproate and risperidone in children ages 3-7 yr. with bipolar disorders. A secondary aim is to carefully characterize these subjects using clinical rating scales and develop pilot data on a very young cohort of children with bipolar disorders that can be used to support an application to NIMH for a prospective, longitudinal study that will provide important information about the course, medication response, neurobiology and outcome of these patients.


Condition Intervention Phase
Bipolar Disorder
Drug: Risperidone Valproate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • YMRS & CGI-I [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • YMRS [ Time Frame: 6 Weesk ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: September 2004
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Risperidone Valproate
    liquid, BID dosing.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients, 3-7 years 11 months of age.
  2. Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
  3. Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) bipolar disorder and must currently display an acute manic, hypomanic or mixed episode as determined by DSM-IV criteria. This includes the following diagnoses: 296.4x, Bipolar I Disorder, Most Recent Episode Manic; 296.6x, Bipolar I Disorder, Most recent Episode Mixed; and 296.0x, Bipolar I Disorder, Single Manic Episode, Bipolar II Disorder, Most Recent Episode Hypomanic.
  4. Patients must have an initial score (at day 0) on the YMRS total score of at least 20.
  5. Subjects and their caretakers should be fluent in English.

Exclusion Criteria:

  1. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
  2. Neurologic disorders including epilepsy, stroke, or severe head trauma.
  3. 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.
  4. Mania due to a general medical condition or substance-induced mania (DSM-IV).
  5. Mental retardation (IQ <70), evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder.
  6. History of hypersensitivity to or intolerance of risperidone or valproate.
  7. Prior history of risperidone or valproate non-response.
  8. Judged clinically to be at serious suicidal risk.
  9. Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
  10. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221403

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45267
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Stanley Medical Research Institute
Investigators
Principal Investigator: Robert A Kowatch, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Robert A. Kowatch, CCHMC
ClinicalTrials.gov Identifier: NCT00221403     History of Changes
Other Study ID Numbers: 03-12-26
Study First Received: September 14, 2005
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
child
adolescent
bipolar disorder

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

ClinicalTrials.gov processed this record on September 29, 2014