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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00761761
Date of registration: 25/09/2008
Primary sponsor: University of Pittsburgh
Public title: Sensoril(Ashwaganhda)for Bipolar Disorder
Scientific 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
Date of first enrolment: October 2008
Target sample size: 60
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Bipolar Disorder NOS
Bipolar I Disorder
Bipolar II Disorder
Drug: Sensoril
Primary Outcome(s)
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. [Time Frame: 8 week treatment]
Secondary Outcome(s)
Sensoril® treatment will secondarily improve any residual mood/anxiety symptoms and impaired metabolic indices [Time Frame: 8 week treatment]
Secondary ID(s)
Chengappa Sensoril
Univ.Pitts IRB# PRO08060267
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Alliance for Research on Schizophrenia and Depression
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