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 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT00961961
Eligibility Criteria:
Inclusion Criteria:
* Men/women (all races and ethnicity)
* Age at least 18 years old
* Bipolar Type I Disorder
* Current Major Depressive Episode
* Able to understand and provide signed informed consent
Exclusion Criteria:
* Current alcohol or drug abuse
* Alcohol or drug dependence within 3 months
* Allergic to Fluoxetine or Lithium
* Unstable medical condition (e.g., uncontrolled thyroid, renal, cardiovascular disease)
* Pregnant or nursing women
* Women of child-bearing potential unwilling to use a medically acceptable form of contraception
* Actively suicidal
* Requiring hospitalization
* Use of medication contraindicated with lithium or fluoxetine
* Unable to participate in a year-long trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00961961
Study Brief:
Protocol Section:
NCT00961961