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:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT00481195
Eligibility Criteria:
Key Inclusion Criteria:
* The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
* The patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid.
Key Exclusion Criteria:
* The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence).
* The patient has any clinically significant uncontrolled medical or surgical condition.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
* The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00481195
Study Brief:
Protocol Section:
NCT00481195