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 @ 12:59 PM
Ignite Modification Date:
2025-12-24 @ 12:59 PM
NCT ID:
NCT00761761
Eligibility Criteria:
Inclusion Criteria:
* DSMIV-TR diagnosis of Bipolar Disorder
* Ages 18 to 65
* Men or Women
* 8th grade education or greater
* Able to provide competent written informed consent
* Current main mood stabilizer and mood status (YMRS and MADRS scores less than or equal to 10) are stable for greater than or equal to 4 weeks by history.
Exclusion Criteria:
* Medically unstable conditions
* Known allergy to Sensoril® (or Ashwagandha)
* Current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder
* Pregnant or lactating women
* Mini-mental score (MMSE) less than or equal to 23
* Currently receiving donepezil, rivastigamine, or galatamine, or memantine or any marketed agent for slowing memory loss in dementia
* Abnormal clinical thyroid status
* Currently (or within past 2 weeks) receiving St. John's Wort, Gingko or Omega-3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00761761
Study Brief:
Protocol Section:
NCT00761761