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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT00411203
Eligibility Criteria:
Inclusion Criteria:
1. diagnosis of BD I, most recent episode, manic or mixed,
2. ages 18-65,
3. Young Mania Rating Scale (YMRS) score \> 20 at screening and baseline,
4. providing written informed consent.
Exclusion Criteria:
1. currently pregnant, planning to become pregnant, or breast feeding,
2. history of any coagulopathies, deep vein thrombosis, pulmonary embolus,
3. a history of hypersensitivity to tamoxifen,
4. drug screen positive for any drug of abuse at screening, active substance abuse in the past 2 weeks or substance dependence in the past 2 months (except nicotine and caffeine),
5. diagnosis of schizophrenia, dementia, delirium, seizure disorder, obsessive compulsive disorder, or major cardiac, hepatic or renal disease that is unstable or that requires medical care,
6. administration of any other investigational drug in the last 30 days,
7. clinically significant suicidal or homicidal ideation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00411203
Study Brief:
Protocol Section:
NCT00411203