Schizophrenia
Conditions
Keywords
Schizophrenia, Withania Somnifera
Brief summary
To determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total score) in persons with schizophrenia. A secondary aim is to determine whether WSE reduces measures of positive and negative symptoms (PANSS subscales) and stress scores on the Perceived Stress Scale (PSS).
Interventions
DRUGWSE
WSE tablets
DRUGPlacebo Oral Tablet
Placebo tablet
Sponsors
Stanley Medical Research Institute
University of Maryland
Chengappa, K.N. Roy, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or schizoaffective disorder * Ability to provide informed written consent * PANSS total score ≥ 70 or a CGI Severity Scored ≥ 4; and at least 2 positive symptom subscale items (i.e., delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content) scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme. * Evidence of a positive symptom exacerbation during the year prior to study entry. * For women of child bearing age, a negative serum pregnancy test at screening
Exclusion criteria
* Testing positive for illicit substances (positivity to marijuana or opioids will be assessed on a case by case basis due to the long elimination half life in the urine of marijuana and the use of opioids for various pain disorders, caffeine and nicotine are excepted) * Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis * Seriously unstable medical illnesses * Pregnant or breast feeding women * Known allergy or history of serious adverse event with WSE * Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior) * Currently receiving antibiotics, anti-viral, or anti-parasitic medications * Currently receiving immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDS associated drugs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptom Scale | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PANSS Negative Factor Score Also Know as Marder Factors | 12 weeks | The 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Withania Somnifera Extract (WSE) WSE 500 mg bid for 12 weeks
WSE: WSE tablets | 24 |
| Placebo Tablets Placebo oral tablet bid for 12 weeks
Placebo Oral Tablet: Placebo tablet | 23 |
| Total | 47 |
Baseline characteristics
| Characteristic | Placebo Tablets | Total | Withania Somnifera Extract (WSE) |
|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 12.1 | 43.7 years STANDARD_DEVIATION 11.4 | 43.7 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 43 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 28 Participants | 16 Participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 6 Participants |
| Sex: Female, Male Male | 20 Participants | 38 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 12 / 24 | 18 / 23 |
| serious Total, serious adverse events | 1 / 24 | 3 / 23 |
Outcome results
Primary
Positive and Negative Symptom Scale
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
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Withania Somnifera Extract (WSE) | Positive and Negative Symptom Scale | Week 0 | 65.0 score on a scale | Standard Error 2.6 |
| Withania Somnifera Extract (WSE) | Positive and Negative Symptom Scale | Week 6 | 63.2 score on a scale | Standard Error 2.4 |
| Withania Somnifera Extract (WSE) | Positive and Negative Symptom Scale | Week 12 | 61.3 score on a scale | Standard Error 2.7 |
| Placebo Tablets | Positive and Negative Symptom Scale | Week 0 | 75.1 score on a scale | Standard Error 2.6 |
| Placebo Tablets | Positive and Negative Symptom Scale | Week 6 | 72.0 score on a scale | Standard Error 2.5 |
| Placebo Tablets | Positive and Negative Symptom Scale | Week 12 | 68.8 score on a scale | Standard Error 2.7 |
p-value: 0.31Mixed Models Analysis
Secondary
PANSS Negative Factor Score Also Know as Marder Factors
The 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
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Withania Somnifera Extract (WSE) | PANSS Negative Factor Score Also Know as Marder Factors | Baseline | 2.05 score on a scale | Standard Deviation 0.84 |
| Withania Somnifera Extract (WSE) | PANSS Negative Factor Score Also Know as Marder Factors | 12 weeks | 2.10 score on a scale | Standard Deviation 0.8 |
| Placebo Tablets | PANSS Negative Factor Score Also Know as Marder Factors | Baseline | 2.68 score on a scale | Standard Deviation 0.67 |
| Placebo Tablets | PANSS Negative Factor Score Also Know as Marder Factors | 12 weeks | 2.45 score on a scale | Standard Deviation 0.69 |