Trial Outcomes & Findings for Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia (NCT NCT03437668)
NCT ID: NCT03437668
Last Updated: 2024-10-08
Results Overview
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Subjects can not score lower than 30 or higher than 210. Higher score indicates higher amount of psychopathology
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
47 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Withania Somnifera Extract (WSE)
WSE 500 mg bid for 12 weeks
WSE: WSE tablets
|
Placebo Tablets
Placebo oral tablet bid for 12 weeks
Placebo Oral Tablet: Placebo tablet
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
Baseline characteristics by cohort
| Measure |
Withania Somnifera Extract (WSE)
n=24 Participants
WSE 500 mg bid for 12 weeks
WSE: WSE tablets
|
Placebo Tablets
n=23 Participants
Placebo oral tablet bid for 12 weeks
Placebo Oral Tablet: Placebo tablet
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Subjects can not score lower than 30 or higher than 210. Higher score indicates higher amount of psychopathology
Outcome measures
| Measure |
Withania Somnifera Extract (WSE)
n=22 Participants
WSE 500 mg bid for 12 weeks
WSE: WSE tablets
|
Placebo Tablets
n=21 Participants
Placebo oral tablet bid for 12 weeks
Placebo Oral Tablet: Placebo tablet
|
|---|---|---|
|
Positive and Negative Symptom Scale
Week 0
|
65.0 score on a scale
Standard Error 2.6
|
75.1 score on a scale
Standard Error 2.6
|
|
Positive and Negative Symptom Scale
Week 6
|
63.2 score on a scale
Standard Error 2.4
|
72.0 score on a scale
Standard Error 2.5
|
|
Positive and Negative Symptom Scale
Week 12
|
61.3 score on a scale
Standard Error 2.7
|
68.8 score on a scale
Standard Error 2.7
|
SECONDARY outcome
Timeframe: 12 weeksThe Marder negative factor is a factor-analysis derived dimension of the Positive and Negative Syndrome Scale (PANSS) that measures negative symptoms of schizophrenia. It's made up of seven items from the PANSS, including: Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic withdrawal, Motor retardation, Active social avoidance, Lack of spontaneity in conversation. Each item is scored from 1 to 7 with a higher score indicating greater severity. Minimum score is 7 and maximum is 49
Outcome measures
| Measure |
Withania Somnifera Extract (WSE)
n=23 Participants
WSE 500 mg bid for 12 weeks
WSE: WSE tablets
|
Placebo Tablets
n=23 Participants
Placebo oral tablet bid for 12 weeks
Placebo Oral Tablet: Placebo tablet
|
|---|---|---|
|
PANSS Negative Factor Score Also Know as Marder Factors
Baseline
|
2.05 score on a scale
Standard Deviation .84
|
2.68 score on a scale
Standard Deviation .67
|
|
PANSS Negative Factor Score Also Know as Marder Factors
12 weeks
|
2.10 score on a scale
Standard Deviation .80
|
2.45 score on a scale
Standard Deviation .69
|
Adverse Events
Withania Somnifera Extract (WSE)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Tablets
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Withania Somnifera Extract (WSE)
n=24 participants at risk
WSE 500 mg bid for 12 weeks
WSE: WSE tablets
|
Placebo Tablets
n=23 participants at risk
Placebo oral tablet bid for 12 weeks
Placebo Oral Tablet: Placebo tablet
|
|---|---|---|
|
Infections and infestations
COVID 19
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Psychiatric disorders
Suicidal ideation
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
8.7%
2/23 • Number of events 2 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
Other adverse events
| Measure |
Withania Somnifera Extract (WSE)
n=24 participants at risk
WSE 500 mg bid for 12 weeks
WSE: WSE tablets
|
Placebo Tablets
n=23 participants at risk
Placebo oral tablet bid for 12 weeks
Placebo Oral Tablet: Placebo tablet
|
|---|---|---|
|
Ear and labyrinth disorders
Objective tinnitus
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
8.7%
2/23 • Number of events 2 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Gastrointestinal disorders
Acid reflux
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
0.00%
0/23 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24 • Number of events 2 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Gastrointestinal disorders
Dry Mouth
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Number of events 2 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea and vomiting
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
General disorders
Fatigue
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Infections and infestations
Endometritis
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back injury
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
0.00%
0/23 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Investigations
Weight loss
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
0.00%
0/23 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Decrease appetite
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Psychiatric disorders
Auditory hallucinations
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/24 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
4.3%
1/23 • Number of events 1 • 12 weeks
Definitions consistent with clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place