We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensoril(Ashwaganhda)for Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00761761
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
K.N. Roy Chengappa, University of Pittsburgh

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Bipolar I Disorder Bipolar II Disorder Bipolar Disorder NOS Drug: Sensoril Other: Placebo Phase 3

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1- Sensoril (Ashwagandha)
Sensoril (Ashwagandha) will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week.
 Drug: Sensoril
Other Name: Ashwagandha
Placebo Comparator: 2 - Placebo
Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week.
 Other: Placebo
Other Name: Sugar Pill


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change From Baseline in Digit-Span Score at 8 Weeks [ Time Frame: 8 week treatment ]

    Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al, 2012). However, the results for Digit span which assesses short term or working memory are presented.

    The raw scores for "digit span" ranges from a minimum of 2 to a maximum of 8. The Digit Span test measures working memory and the longer the span the better the cognition therefore the higher score is the better outcome.



Secondary Outcome Measures :
  1. Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms [ Time Frame: Baseline and 8 week treatment ]
    Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Minimum score = 0, Maximum score = 60. Higher scores on MADRS indicate worse functioning.

  2. Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania. [ Time Frame: Baseline and 8 weeks treatment ]
    Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.

  3. Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms [ Time Frame: Baseline and 8 week treatment ]
    Symptoms of anxiety were measured using the Hamilton Anxiety Rating Scale (HARS). Minimum score = 0, Maximum score = 60. Higher scores on HARS indicate worse functioning


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761761


Locations
Layout table for location information
United States, Pennsylvania
Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2593
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Alliance for Research on Schizophrenia and Depression
Investigators
Layout table for investigator information
Principal Investigator: K. N. Roy Chengappa, MD Western Psychiatric Institute and Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: K.N. Roy Chengappa, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00761761    
Other Study ID Numbers: Chengappa Sensoril
Univ.Pitts IRB# PRO08060267
First Posted: September 29, 2008    Key Record Dates
Results First Posted: April 14, 2016
Last Update Posted: April 14, 2016
Last Verified: March 2016
Keywords provided by K.N. Roy Chengappa, University of Pittsburgh:
Sensoril
Bipolar Illness
Cognitive enhancement
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Bipolar Disorder
Pathologic Processes
 Bipolar and Related Disorders
Mood Disorders
Mental Disorders