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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT00580268
Eligibility Criteria:
Inclusion Criteria:
1. medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period;
2. euthymic at the time of conception;
3. able to give informed consent and comply with study procedures;
4. have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45
Exclusion Criteria:
1. active suicidality or homicidality;
2. active substance use disorder with 6 months prior to enrollment, or
3. positive urine drug screen at enrollment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00580268
Study Brief:
Protocol Section:
NCT00580268