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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT01191918
Eligibility Criteria:
Inclusion Criteria:
1. Patients have DSM-IV diagnosis of bipolar disorder with acute manic episode who are admitted as inpatient
2. Young Mania Rating Scale (YMRS) total score \>20 (based on mean scores of two ratings after admission)
3. Physical examination, laboratory results (eg.EKG) from screening visit normal, or abnormal clinically insignificant
Exclusion Criteria:
1. Having history of allergy to donepezil or Lithium.
2. Having active suicide or homicide attempt or intent
3. Having severe medical conditions or taking multiple medications for medical conditions
4. Investigational drug treatment within past 30 days
5. Having a drug screen positive for any drug of abuse at screening
6. Self-report of active substance abuse in the past 2 weeks or substance dependence in the past 2 months
7. Diagnosis of schizophrenia, dementia, delirium, seizure disorder, obsessive compulsive disorder, or unstable medical condition
8. Administration of any investigational drug within 30 days of screening
9. Pregnancy or lactation
10. Asthma requiring chronic medication treatment or ongoing use of anticholinergic medications or cholinomimetics
11. Other factors that investigator consider not suitable for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01191918
Study Brief:
Protocol Section:
NCT01191918