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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00771134
Eligibility Criteria:
Patients suffering from a major depressive episode of bipolar II or I disorder, according to DSM-IV TR
Inclusion Criteria:
* Current major depressive episode of bipolar II or I disorder, according to DSM-IV TR
* Moderate to severe depression
* History of at least one documented mania or hypomania episode
* Absence of current mania or hypomania
Exclusion Criteria:
* Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR
* Any substance disorder with the previous 6 months
* Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
* ECT within 6 months before the study
* Female of childbearing potential and not using adequate contraception
* Other protocol-defined inclusion and exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00771134
Study Brief:
Protocol Section:
NCT00771134