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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00048802
Eligibility Criteria:
Inclusion criteria:
* Have a diagnosis of Bipolar I Disorder;
* Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode;
* Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa);
* Live in the NY Metropolitan area;
* Able to attend weekly to biweekly office visits
Exclusion Criteria:
* Medical contraindication to treatment with lithium and divalproex
* Seizure disorder
* Pregnancy
* Unwillingness to use acceptable methods of birth control if sexually active
* IQ less than 70
* Substance-induced mood disorder or mood disorder due to a general medical condition
* Prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study
* Potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode
* High risk for running away or truancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT00048802
Study Brief:
Protocol Section:
NCT00048802