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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00761761 |
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Date of registration:
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25/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sensoril(Ashwaganhda)for Bipolar Disorder
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Scientific title:
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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 |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00761761 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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K. N. Roy Chengappa, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Western Psychiatric Institute and Clinic |
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Key inclusion & exclusion criteria
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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:
All
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Health Condition(s) or Problem(s) studied
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Bipolar I Disorder
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Bipolar II Disorder
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Bipolar Disorder NOS
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Intervention(s)
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Drug: Sensoril
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Other: Placebo
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Primary Outcome(s)
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Change From Baseline in Digit-Span Score at 8 Weeks
[Time Frame: 8 week treatment]
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Secondary Outcome(s)
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Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.
[Time Frame: Baseline and 8 weeks treatment]
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Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms
[Time Frame: Baseline and 8 week treatment]
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Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms
[Time Frame: Baseline and 8 week treatment]
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Secondary ID(s)
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Univ.Pitts IRB# PRO08060267
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Chengappa Sensoril
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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