Sensoril(Ashwaganhda)for Bipolar Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | March 2011 |
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
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.
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.
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 indices.
RESEARCH PLAN:
We will conduct a randomized, placebo controlled, add on treatment trial of Sensoril® (added
to ongoing prescribed pharmacological mood stabilizer) 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.
METHODS:
Up to Seventy-six subjects with DSM IV bipolar I disorder will be recruited from Western
Psychiatric Institute and Clinic. Using a 1:1 randomization, subjects who sign an informed
consent document will be randomized to receive Sensoril® or placebo.
It is expected that 16 of the 76 subjects may not meet inclusion/exclusion criteria, leaving
60 consenting adults (18 to 65 years) with DSM IV-TR Bipolar Disorder who will be assessed
for euthymia (Young Mania Rating Scale Score of less than or equal to 10, Montgomery Asberg
Depression Rating Scale Score of less than or equal to 10) over the period of 4 weeks while
receiving stable doses of their current mood stabilizer. They will also be assessed for
cognitive dysfunction (attention/executive function, immediate and declarative memory,
psychomotor performance) using Cogtest - a proprietary neuropsychological battery of tests.
These subjects will be characterized for normal pre-morbid IQ, no ECT treatment in past 6
months, no alcohol or substance dependence in past 6 months, mini-mental state score of 23
or more.
Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day,
increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if
tolerability is an issue) will be continued fora total of 8 weeks. Sensoril® is not known to
have interactions with psychotropic drugs, but mood-stabilizer levels will be monitored at
the beginning and end of the study. The principal investigator has worked with a New Jersey
based company (Natreon, Inc.) to obtain an IND from the FDA for Sensoril® treatment of
cognitive dysfunction in persons with Bipolar disorder (IND #102616).
Standard psychopathology rating scales will be administered to evaluate impact if any on
residual symptoms of bipolar disorder. Laboratory indices (glucose/lipids) will be evaluated
at baseline and end of study. Safety will be assessed through a comprehensive health
assessment, including medical history, and evaluation of laboratory measures. Any adverse
effects will be assessed by asking questions at each visit, and if necessary, follow up via
telephone contact or bringing subjects in for assessments outside the scheduled visits.
SIGNIFICANCE:
Cognitive dysfunction can seriously hinder improved functional outcomes in persons with
bipolar disorder. If this short term intervention with Sensoril® shows promise, more
definitive studies using adequate powered sample sizes, and of longer duration can be
conducted. If improvements in cognitive problems are linked to improved functional outcomes
using such supplemental treatments, an important therapeutic milestone in bipolar disorder
will have been achieved.
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 indices.
RESEARCH PLAN:
We will conduct a randomized, placebo controlled, add on treatment trial of Sensoril® (added
to ongoing prescribed pharmacological mood stabilizer) 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.
METHODS:
Up to Seventy-six subjects with DSM IV bipolar I disorder will be recruited from Western
Psychiatric Institute and Clinic. Using a 1:1 randomization, subjects who sign an informed
consent document will be randomized to receive Sensoril® or placebo.
It is expected that 16 of the 76 subjects may not meet inclusion/exclusion criteria, leaving
60 consenting adults (18 to 65 years) with DSM IV-TR Bipolar Disorder who will be assessed
for euthymia (Young Mania Rating Scale Score of less than or equal to 10, Montgomery Asberg
Depression Rating Scale Score of less than or equal to 10) over the period of 4 weeks while
receiving stable doses of their current mood stabilizer. They will also be assessed for
cognitive dysfunction (attention/executive function, immediate and declarative memory,
psychomotor performance) using Cogtest - a proprietary neuropsychological battery of tests.
These subjects will be characterized for normal pre-morbid IQ, no ECT treatment in past 6
months, no alcohol or substance dependence in past 6 months, mini-mental state score of 23
or more.
Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day,
increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if
tolerability is an issue) will be continued fora total of 8 weeks. Sensoril® is not known to
have interactions with psychotropic drugs, but mood-stabilizer levels will be monitored at
the beginning and end of the study. The principal investigator has worked with a New Jersey
based company (Natreon, Inc.) to obtain an IND from the FDA for Sensoril® treatment of
cognitive dysfunction in persons with Bipolar disorder (IND #102616).
Standard psychopathology rating scales will be administered to evaluate impact if any on
residual symptoms of bipolar disorder. Laboratory indices (glucose/lipids) will be evaluated
at baseline and end of study. Safety will be assessed through a comprehensive health
assessment, including medical history, and evaluation of laboratory measures. Any adverse
effects will be assessed by asking questions at each visit, and if necessary, follow up via
telephone contact or bringing subjects in for assessments outside the scheduled visits.
SIGNIFICANCE:
Cognitive dysfunction can seriously hinder improved functional outcomes in persons with
bipolar disorder. If this short term intervention with Sensoril® shows promise, more
definitive studies using adequate powered sample sizes, and of longer duration can be
conducted. If improvements in cognitive problems are linked to improved functional outcomes
using such supplemental treatments, an important therapeutic milestone in bipolar disorder
will have been achieved.
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
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Pittsburgh, Pennsylvania 15213
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