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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00150605
Eligibility Criteria:
Inclusion Criteria:
* DSM-IV criteria for Bipolar I disorder
* Screening YMRS score =\>16
* Women of childbearing potential agree to take adequate precautions against contraception
* Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic
Exclusion Criteria:
* Hospitalization required for treatment of psychiatric symptoms
* Patients who meet DSM-IV for ultra-rapid cycling
* History of serious suicide attempt requiring medical intervention
* Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00150605
Study Brief:
Protocol Section:
NCT00150605