Bipolar I Disorder Clinical Trial
Official title:
Sensoril® (Ashwagandha) - A Standardized Extract From a Medicinal Plant - (Withania Somnifera) for Cognitive Enhancement in Persons With Bipolar Disorder: A Parallel Group, Randomized Double Blind, and Placebo Controlled Study
Verified date | January 2013 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 ability) in persons with bipolar disorder. Secondarily, the investigators
hypothesize there will be secondary improvements in residual mood/anxiety symptoms, and
metabolic indices, if impaired (fasting blood glucose and lipids).
The investigators aim to test these hypotheses by conducting a randomized, placebo
controlled, add on treatment trial of Sensoril® (added to existing mood stabilizer
treatment) recruiting 60 subjects with DSM IV-TR bipolar disorder for a period of 8 weeks.
Measures of cognition, psychopathology and laboratory indices will be utilized for
evaluating primary and secondary outcomes, along with safety assessments.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania |
United States | Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Alliance for Research on Schizophrenia and Depression |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensoril® treatment of persons with bipolar illness will improve their cognitive outcomes, specifically, measures of attention and executive function, and verbal and visuopatial memory relative to placebo treatment. | 8 week treatment | No | |
Secondary | Sensoril® treatment will secondarily improve any residual mood/anxiety symptoms and impaired metabolic indices | 8 week treatment | No |
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