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 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT01996293
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* If Pregnant, equal to or less than 26 weeks
* English-speaking
* DSM-IV Bipolar Disorder, any subtype
* Able to provide informed consent
* Daily dosing of Lamictal
Exclusion Criteria:
* Active substance abuse within last 6 months and/or positive urine drug screen
* Active suicidality
* No obstetrical care
* Antiepileptic drugs that affect metabolism of LTG
* Medications in FDA categories F or X that are not antimanic drugs
* Liver or kidney disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01996293
Study Brief:
Protocol Section:
NCT01996293