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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT01588457
Eligibility Criteria:
Inclusion Criteria:
* DSM-IV TR (Diagnostic and Statistical Manual Edition IV Text Revision) diagnosis BD I or II as assessed by MINI PLUS (Mini International Neuropsychiatric Interview PLUS)
* Male or female ≥ 18 years old
* Currently symptomatic with a CGI-BP-S ≥3 for mania/hypomania \&/or depression for ≥ 2 weeks
* One of the following indicators of recent active illness: a depressive or manic or hypomanic or mixed episode in the past 12 months
* If female of child bearing age must use effective birth control.
Exclusion Criteria:
* Unwilling or unable to comply with study requirements
* Renal impairment (serum creatinine \> 1.5 mg/dL)
* If maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1
* Patients who have had intolerable side effects to QTP, Li, Div, or LTG
* Patients whose clinical status requires inpatient care
* Drug/alcohol dependence within the past 30 days
* Pregnancy as determined by serum pregnancy test or breastfeeding
* History of poor response to Li at a serum Li of ≥ 0.5 mEq/L (milliequivalents per Liter) or Div at a serum level of ≥ 45 mg/dL for at least 2 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01588457
Study Brief:
Protocol Section:
NCT01588457