Bipolar I DisorderPhase 3NCT00761761
Sensoril(Ashwaganhda)for Bipolar Disorder
A Phase 3 study testing Sensoril in people with Bipolar I Disorder and Bipolar II Disorder, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS
- What is being tested?
- Sensoril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Mar 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-2593
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
Read the 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.
- Being tested
- Sensoril, Placebo
- Keywords
- Sensoril, Bipolar Illness, Cognitive enhancement
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SensorilDrug
Also called Ashwagandha
PlaceboOther
Also called Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| 1- Sensoril (Ashwagandha) | Experimental | 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. Receives: Drug: Sensoril |
| 2 - Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Digit-Span Score at 8 Weeks
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.
Measured: 8 week treatment
Secondary outcomes (3)
Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms
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.
Measured: Baseline and 8 week treatment
Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.
Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.
Measured: Baseline and 8 weeks treatment
Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms
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
Measured: Baseline and 8 week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, K.N. Roy Chengappa, University of Pittsburgh
- Investigators
- K. N. Roy Chengappa, MD, Principal investigator, Western Psychiatric Institute and Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761761
- Sponsor's protocol ID
- Chengappa Sensoril
- Other IDs
- Univ.Pitts IRB# PRO08060267
- Status last verified
- Mar 2016
- First submitted
- 25 Sep 2008
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chengappa KN, Bowie CR, Schlicht PJ, Fleet D, Brar JS, Jindal R. Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. J Clin Psychiatry. 2013 Nov;74(11):1076-83. doi: 10.4088/JCP.13m08413.
PubMed 24330893
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00761761
- Acronym / sponsor ID
- Chengappa Sensoril
- Keywords
- Sensoril, Bipolar Illness, Cognitive enhancement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Posted 14 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- Sensoril (Ashwagandha) | Experimental | Drug: SensorilSensoril (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. |
| 2 - Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SensorilAlso: Ashwagandha | Drug | 1- Sensoril (Ashwagandha) |
| PlaceboAlso: Sugar Pill | Other | 2 - Placebo |
Primary outcome
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.
3 secondary outcomes
Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms
Time frame: Baseline and 8 week treatment
Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.
Time frame: Baseline and 8 weeks treatment
Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms
Time frame: Baseline and 8 week treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24330893Chengappa KN, Bowie CR, Schlicht PJ, Fleet D, Brar JS, Jindal R. Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. J Clin Psychiatry. 2013 Nov;74(11):1076-83. doi: 10.4088/JCP.13m08413.
- Connect to NARSAD list of active research studiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K. N. Roy Chengappa, MD principal investigator
Western Psychiatric Institute and Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sensoril in people with Bipolar I Disorder and Bipolar II Disorder, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Digit-Span Score at 8 Weeks (time frame: 8 week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00761761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.