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:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00250367
Eligibility Criteria:
Inclusion Criteria:
* Patients hospitalized for mania with a score \>=20 on the Young Mania Rating Scale (YMRS). (Patients with symptoms of depression are eligible)
* diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
* receiving treatment with a mood stabilizer for a minimum of 2 weeks prior to study initiation, or beginning therapy with a mood stabilizer prior to treatment with study medication
* patients medically stable on the basis of physical examination, medical history and electrocardiogram results.
Exclusion Criteria:
* Other Axis I DSM-IV diagnosis (except nicotine or caffeine dependence)
* history of alcohol or drug abuse or dependence within 3 months of starting the study
* seizure disorder requiring medication
* known sensitivity to risperidone, lithium, valproate or carbamazepine
* pregnant or nursing females, or those lacking adequate contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00250367
Study Brief:
Protocol Section:
NCT00250367