Phase 3
Completed N=46
Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
Source: ClinicalTrials.gov NCT00221403 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: YMRS — 10; 18.82; 4.29 score on a scale
◆ Published Evidence
Established
24citations · ~2 / year
Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder.
Summary
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.
Linked Publications
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Placebo-controlled trial of valproic Acid versus risperidone in children 3-7 years of age with bipolar I disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY YMRS |
10; 18.82; 4.29 | — |
Eligibility 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.
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Data sourced from ClinicalTrials.gov (NCT00221403) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.