Phase 3
Completed N=60
Sensoril(Ashwaganhda)for Bipolar Disorder
Bipolar I Disorder · Bipolar II Disorder · Bipolar Disorder NOS
Source: ClinicalTrials.gov NCT00761761 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Change From Baseline in Digit-Span Score at 8 Weeks — 0.73; 0.17 units on a scale
◆ Published Evidence
Highly cited
114citations · ~9 / year
Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder.
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 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.
Linked Publications
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Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Digit-Span Score at 8 Weeks |
0.73; 0.17 | — |
| SECONDARY Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms |
6.2; 4.8; 4.8; 4.1 | — |
| SECONDARY Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania. |
3.9; 3.7; 2.8; 3.2 | — |
| SECONDARY Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms |
3.8; 5.3; 3.2; 4.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00761761) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.