Trial Outcomes & Findings for Sensoril(Ashwaganhda)for Bipolar Disorder (NCT NCT00761761)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

8 week treatment

Results posted on

2016-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Sensoril Ashwagandha -1 Sensoril(Ashwagandha) Sensoril: 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 for a total of 8 weeks.	Placebo - 2 Placebo Sensoril: 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 for a total of 8 weeks.
Overall Study STARTED	30	30
Overall Study COMPLETED	24	29
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sensoril Ashwagandha -1 Sensoril(Ashwagandha) Sensoril: 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 for a total of 8 weeks.	Placebo - 2 Placebo Sensoril: 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 for a total of 8 weeks.
Overall Study Lost to Follow-up	3	1
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

Sensoril(Ashwaganhda)for Bipolar Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sensoril n=30 Participants Sensoril(Ashwagandha) Sensoril: Sensoril® 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 for a total of 8 weeks.	Placebo n=30 Participants 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 and will be continued for a total of 8 weeks.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46.9 years STANDARD_DEVIATION 10.38 • n=5 Participants	45.93 years STANDARD_DEVIATION 10.40 • n=7 Participants	46.42 years STANDARD_DEVIATION 10.49 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sensoril n=24 Participants Sensoril(Ashwagandha) Sensoril: 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 for a total of 8 weeks.	Placebo n=29 Participants Placebo Sensoril: 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 for a total of 8 weeks.
Change From Baseline in Digit-Span Score at 8 Weeks	0.73 units on a scale Standard Error 0.19	0.17 units on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline and 8 week treatment

Population: Stable Bipolar patients

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.

Outcome measures

Outcome measures
Measure	Sensoril n=29 Participants Sensoril(Ashwagandha) Sensoril: 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 for a total of 8 weeks.	Placebo n=30 Participants Placebo Sensoril: 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 for a total of 8 weeks.
Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms Baseline	6.2 units on a scale Standard Deviation 3.6	4.8 units on a scale Standard Deviation 3.6
Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms 8 weeks	4.8 units on a scale Standard Deviation 4.3	4.1 units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: Baseline and 8 weeks treatment

Population: Stable Bipolar Patients

Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.

Outcome measures

Outcome measures
Measure	Sensoril n=29 Participants Sensoril(Ashwagandha) Sensoril: 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 for a total of 8 weeks.	Placebo n=30 Participants Placebo Sensoril: 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 for a total of 8 weeks.
Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania. Baseline	3.9 units on a scale Standard Deviation 2.3	3.7 units on a scale Standard Deviation 2.2
Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania. 8 Weeks	2.8 units on a scale Standard Deviation 2.4	3.2 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline and 8 week treatment

Population: Stable Bipolar Patients

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

Outcome measures

Outcome measures
Measure	Sensoril n=29 Participants Sensoril(Ashwagandha) Sensoril: 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 for a total of 8 weeks.	Placebo n=30 Participants Placebo Sensoril: 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 for a total of 8 weeks.
Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms Baseline	3.8 units on a scale Standard Deviation 4.5	5.3 units on a scale Standard Deviation 5.6
Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms 8 weeks	3.2 units on a scale Standard Deviation 5.6	4.1 units on a scale Standard Deviation 5.8

Adverse Events

Sensoril

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sensoril n=30 participants at risk Sensoril(Ashwagandha) Sensoril: 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 for a total of 8 weeks.	Placebo n=30 participants at risk Placebo Sensoril: 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 for a total of 8 weeks.
Gastrointestinal disorders diarrhea	16.7% 5/30 • Number of events 5	3.3% 1/30 • Number of events 1

Additional Information

K.N. Roy Chengappa, MD

Univeristy Of Pittsburgh Medical Center

Phone: 412-246-5006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place