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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT00211250
Eligibility Criteria:
Inclusion Criteria:
* Bipolar I and II patients, age 18 and older, currently tolerating a stable dose of Valproic Acid for at least 3 months with a current Valproic Acid level of at least 50 mcg/mL at screening and baseline,
Exclusion Criteria:
* Women who are pregnant or breast feeding or intending to become pregnant, contraindication or history of hypersensitivity to valproic acid, DVPX or DVPX ER.
* Clinically significant organ disease, clinically significant abnormalities in physical examination, EKG, or lab test, history of any disease which in the investigator's opinion may confound the results of the study or pose additional risk.
* Other principle nonpsychotic or psychotic psychiatric diagnosis. Patients weighing \>300 pounds.
* Patients taking any other mood stabilizers.
* Patients not already on a stable dose of valproic acid or have a Valproic Acid level less than 50 mcg/mL at screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00211250
Study Brief:
Protocol Section:
NCT00211250