Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
This study has been completed.
Sponsor:
Children's Hospital Medical Center, Cincinnati
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
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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:
- Male or female patients, 3-7 years 11 months of age.
- 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.
- 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.
- Patients must have an initial score (at day 0) on the YMRS total score of at least 20.
- Subjects and their caretakers should be fluent in English.
Exclusion Criteria:
- Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
- Neurologic disorders including epilepsy, stroke, or severe head trauma.
- 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 (DSM-IV).
- Mental retardation (IQ <70), evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder.
- History of hypersensitivity to or intolerance of risperidone or valproate.
- Prior history of risperidone or valproate non-response.
- Judged clinically to be at serious suicidal risk.
- Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
-
Contacts and Locations
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 Affective Disorders, Psychotic Mood Disorders Mental Disorders Valproic Acid Risperidone Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Antagonists Serotonin Agents Antipsychotic Agents Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013