Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00221403
Eligibility 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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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
7 Years
Study:
NCT00221403
Study Brief:
Protocol Section:
NCT00221403