Status:
COMPLETED
Sensoril(Ashwaganhda)for Bipolar Disorder
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Bipolar I Disorder
Bipolar II Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance cognitive abilities (specifically measures of attention, executive function, working memory, and visuospatial ...
Detailed Description
OBJECTIVE: To evaluate if Sensoril® treatment of persons with bipolar illness will improve their cognitive performance and if it will improve residual mood/anxiety symptoms and impaired metabolic ind...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00761761
Start Date
October 1 2008
End Date
March 1 2011
Last Update
April 14 2016
Active Locations (2)
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1
Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2593
2
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213