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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT00374920
Eligibility Criteria:
Inclusion Criteria:
* bipolar I disorder with acute manic or mixed episode, with or without psychotic features
* YMRS score of at least 20
* history of at least one previous manic or mixed episode requiring treatment in the last 10 years
Exclusion Criteria:
* history of failing to respond to treatment with two or more adequate trials of approved anti-manic medications for the current episode
* Axis I or Axis II disorder (other than bipolar I disorder) that requires treatment or has been the primary subject of treatment in the past 3 months
* defined substance abuse or dependency within the 3 months
* schizophrenia, schizoaffective disorder, delusional disorder, mental retardation or pervasive developmental disorder
* suicidal or danger to others
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00374920
Study Brief:
Protocol Section:
NCT00374920