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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00199966
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Bipolar I or II confirmed by K-SADS and clinical interview.
* Ages 6 to 17 years 11 months.
* YMRS score of \<10, this is consistent with minimal symptoms of mania. Or a desire to change medications due to a simplified dosing schedule or to reduce unwanted side effects of divalproex sodium.
* Ability and willingness of subject and parent(s)/guardian(s) to provide informed written assent/consent.
Exclusion Criteria:
* Diagnosis of: Pervasive Developmental Disorders, Schizophrenia spectrum disorders, Obsessive Compulsive Disorder.
* Concurrent medical conditions requiring medication or that are unstable.
* Current suicidal thoughts.
* Recent suicidal behavior.
* Pregnancy or sexually active female not using a reliable form of contraception.
* Previous inadequate response to DVP ER.
* Known hypersensitivity to DVP or DVP ER.
* Recent inpatient hospitalization for suicidality or homicidality, (last 6 months).
* Subjects who are clinically stable and not suffering significant side effects on their current medical regimen.
* Use of antidepressants within the last 2 weeks, 4 weeks for fluoxetine.
* Recent (last 3 months) substance abuse or dependence. Urine drug screen will be obtained if a question arises.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT00199966
Study Brief:
Protocol Section:
NCT00199966