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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT01117220
Eligibility Criteria:
Inclusion Criteria:
* Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed)
* At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17.
* The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive
Exclusion Criteria:
* Imminent risk of suicide or homicide, as judged by the site investigator
* Any history of serious or unstable illness
* Risk for prolonged QT
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT01117220
Study Brief:
Protocol Section:
NCT01117220