A Phase 3 interventional study of Sensoril and Placebo in Bipolar I Disorder, Bipolar II Disorder and Bipolar Disorder NOS, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-14.
Sponsored by University of Pittsburgh · Phase 3, Interventional, and Treatment
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.
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 60 is close to the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Also known as: Ashwagandha
Also known as: Sugar Pill
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.
Time frame: 8 week treatment
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.
Time frame: 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.
Time frame: 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
Time frame: Baseline and 8 week treatment
| Milestone | Sensoril Ashwagandha -1 | Placebo - 2 |
|---|---|---|
| Started | 30 | 30 |
| Completed | 24 | 29 |
| Not completed | 6 | 1 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Withdrawal by subject | 3 | 0 |
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.
| units on a scale | Sensoril | Placebo |
|---|---|---|
| Change From Baseline in Digit-Span Score at 8 Weeks | 0.73 ± 0.19 | 0.17 ± 0.18 |
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.
| units on a scale | Sensoril Ashwagandha -1 | Placebo - 2 |
|---|---|---|
| Baseline | 6.2 ± 3.6 | 4.8 ± 3.6 |
| 8 weeks | 4.8 ± 4.3 | 4.1 ± 4.7 |
Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.
| units on a scale | Sensoril Ashwagandha -1 | Placebo - 2 |
|---|---|---|
| Baseline | 3.9 ± 2.3 | 3.7 ± 2.2 |
| 8 Weeks | 2.8 ± 2.4 | 3.2 ± 2.7 |
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
| units on a scale | Sensoril Ashwagandha -1 | Placebo - 2 |
|---|---|---|
| Baseline | 3.8 ± 4.5 | 5.3 ± 5.6 |
| 8 weeks | 3.2 ± 5.6 | 4.1 ± 5.8 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sensoril | — | 0/30 (0%) | 5/30 (16.7%) |
| Placebo | — | 0/30 (0%) | 1/30 (3.3%) |
| Event | Sensoril | Placebo |
|---|---|---|
| diarrheaGastrointestinal disorders | 5/30 | 1/30 |
| Age, Categorical(Participants) | Sensoril | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 30 | 60 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Sensoril | Placebo | Total |
|---|---|---|---|
| Mean | 46.9 ± 10.38 | 45.93 ± 10.40 | 46.42 ± 10.49 |
| Sex: Female, Male(Participants) | Sensoril | Placebo | Total |
|---|---|---|---|
| Female | 13 | 10 | 23 |
| Male | 17 | 20 | 37 |
| Region of Enrollment(participants) | Sensoril | Placebo | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
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