Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nationwide Children's Hospital
With
Stanley Medical Research Institute
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.
Age
3–7
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
