Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Sensoril, Withania Somnifera extract, Total/ Positive / Negative Symptoms, Stress, Inflammation, Immunomodulation
Brief summary
Withania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or to build resistance to stress or diseases in indigenous medical systems in India for centuries. Modern scientific data for WSE indicate several bioactive molecules (withanolides, withanosides, indosides, withaferin-A, others) with significant immunomodulatory, anti-inflammatory and stress reducing properties. This study will examine whether a standardized extract of Withania Somnifera (WSE; Sensoril®) will improve total, positive, negative symptoms, and stress in patients with schizophrenia. The study will examine whether WSE reduces PANSS positive and negative symptoms and stress scores in subjects, and whether these improvements are mediated by changes in inflammatory immune indices. An additional aim will determine if patients receiving WSE will have fewer adjustments to their psychotropic medications that those assigned to placebo. The study will examine whether WSE will re-balance Th1/Th2 ratios (cytokine measures) and mediate a reduction of elevated hs-CRP levels. It is hypothesized that those subjects whose Th1/Th2 ratios normalize will likely have a greater magnitude of clinical improvement versus those subjects whose immune ratios remain unbalanced. The proposal is a 12-week, double-blind, placebo-controlled RCT of WSE added to antipsychotic medications in approximately 60 or more patients with schizophrenia with an exacerbation of symptoms. If efficacy is affirmed, this low cost extract could be studied further, and used quite readily across low, middle and high income countries.
Detailed description
The primary aim is to determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total) and stress scores(PSS total) in persons with schizophrenia? The study will also determine whether WSE reduces measures of positive and negative and general symptoms of schizophrenia (PANSS subscale scores)? Another primary aim will be to determine if changes in antipsychotic and/or other psychotropic medications (lithium, anticonvulsants, antidepressants, anxiolytic agents or hypnotics) (examples: dosage escalation or reductions or switch or stoppage) will favor the group receiving the standardized Withania somnifera extract versus those receiving placebo. Even though we expect changes in antipsychotic medications to occur when patients experience an exacerbation of psychotic symptoms (or other psychiatric symptoms), we hypothesize that those receiving the standardized Withania somnifera extract will experience fewer medication adjustments then those assigned to placebo. A secondary aim is to determine whether WSE will rebalance TH1/TH2 ratios (cytokine measures) and mediate a reduction of elevated hs-CRP levels? The study will assess whether those subjects whose TH1/TH2 ratios normalize have a greater magnitude of clinical improvement vs. those subjects whose immune ratios remain unbalanced. Similarly, the study will assess whether reduction of hsCRP levels correlate with improvements in PANSS total and subscale scores or the PSS total scores. Eighty or more patients with DSM IV TR (or if instituted by the study initiation: DSM V) schizophrenia or schizoaffective disorder will be screened and 60 or more eligible patients will be enrolled in a 12 week placebo controlled double blind study. Subjects who have experienced an exacerbation of positive symptoms (delusions, hallucinations, etc). Subjects receiving medications that affect the immune-inflammatory system will be excluded and those receiving antibiotics, antiviral or anti-parasitic medications will be excluded. Base line laboratory and EKG examination will be carried out to establish eligibility for study participation. In addition specific laboratory analyses of immune markers namely interleukin-2, interferon gamma, interleukin-4, interleukin 6 and high sensitivity C-Reactive Protein will be carried out. Sixty or more patients will be randomly assigned to receive either WSE or matching placebo starting with 1 capsule of 250 mg strength twice a day (total daily dose = 500 mg) for the first week which will be increased to 2 capsules of 250 mg twice daily (total daily dose = 1000 mg) for a total treatment period of 12 weeks. An assessment of psychopathology (PANSS) and stress will be carried out at each scheduled visit. Assessments of safety including vital signs and treatment emergent adverse events will also be carried out at each visit. Immune-inflammatory markers will be re-assessed at the final visit.
Interventions
DRUGSensoril®
Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera
DRUGPlacebo
Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.
Sponsors
K.N. Roy Chengappa
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 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adult males or females (≥ 18 years, to 75 years) 2. DSM IV TR diagnosis of schizophrenia or schizoaffective disorder (If officially instituted by study initiation: DSM V diagnoses will be used). 3. Ability to provide informed written consent 4. PANSS total score ≥ 60, positive symptom cluster, (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content with at least 2 items scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme 5. Current symptom exacerbation ≥ 2 weeks, but ≤ 1 year 6. Receiving anti-psychotic medications for ≥ 4 weeks 7. For women of child bearing age, a negative pregnancy test at screening.
Exclusion criteria
1. Testing positive for illicit substances (marijuana or alcohol use will be assessed on a case by case basis, caffeine and nicotine are excepted) 2. Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis 3. Seriously unstable medical illnesses 4. Pregnant or breast feeding women 5. Known allergy or history of serious adverse event with WSE 6. Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior) 7. Currently receiving antibiotics, anti-viral, or anti-parasitic medications 8. Currently receiving immunosuppressive medications (e.g. corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs). 9. Currently receiving NSAIDs or Aspirin (\>81 mg/day) on a daily basis or PRN use \> 2x/week (in the last 4 weeks).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Baseline and 12 Weeks | The Positive and Negative Syndrome Scale (PANSS) measures symptom severity in patients with psychotic illnesses. It yields a total score as well as subscores for Positive symptoms, Negative symptoms and General symptoms. PANSS Positive subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome. PANSS Negative subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome. General Psychopathology subscale consists of 16 items - (minimum score = 16, maximum score = 112) - Higher values represent a worse outcome. PANSS Total Score - The 3 subscales scores are summed to compute a PANSS Total score. The minimum PANSS total score = 30, maximum = 210 - Higher values represent a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale | 12 weeks | The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: Possible ratings are: 1= Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5= Minimally worse, 6= Much worse, 7=Very much worse. The higher the score the worse outcome |
| Immune Marker IL-2 | Baseline and 12 weeks or end of study | Changes in immune marker IL-2 will be assessed in response to study medication. |
| Immune Marker IL-4 | Baseline and12 weeks or end of study | Changes in immune marker IL-4 will be assessed in response to study medication. |
| Immune Marker IL-6 | Changes from Baseline in Immune markers at 12 weeks or end of study | Changes in immune marker IL-6 will be assessed in response to study medication. |
| Immune Marker IFN-Y (Gamma) | Baseline and 12 weeks or end of study | Changes in immune marker IFN-Y (gamma) will be assessed in response to study medication. |
| Immune Marker Hs-CRP (High Sensitivity C Reactive Protein) | Baseline and 12 weeks or end of study | Changes in immune marker hs-CRP (high sensitivity C Reactive Protein) will be assessed in response to study medication. hsCRP - mg/L |
| Immune Marker S-100B | Baseline and 12 weeks or end of treatment | Changes in immune marker S-100B will be assessed in response to study medication. Elisa * Sensitivity 2.7 picogm/ml * Range 2.7 to 2000 picogm/ml |
| Perceived Stress Scale (PSS) | Baseline and 12 weeks or end of treatment | The Perceived Stress Scale (PSS) was developed to measure the degree to which situations in one's life are appraised as stressful. Perceived Stress Scale Scoring Each item is rated on a 5-point scale ranging from never (0) to very often (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress. PSS-10 scores are obtained by reversing the scores on the four positive items: For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Total score can range from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress, |
| Clinical Global Impression Scale (CGI-S) - Severity | Baseline and 12 weeks or end of study | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 0 = not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients - The higher the score the worse outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs - Pulse | Baseline and 12 weeks or end of study | Clinically significant changes in Pulse will be assessed for normal or abnormal following randomization to 12 weeks or end of study. |
| Vital Signs - Weight | Baseline and 12 weeks or end of study | Clinically significant changes in weight will be assessed for normal or abnormal following randomization to 12 weeks or end of study |
| Vital Signs - Body Mass Index | Baseline and 12 weeks or end of study | Clinically significant changes in BMI will be assessed for normal or abnormal following randomization to 12 weeks or end of study. |
| Laboratory Analytes | Change from Baseline in Laboratory Analytes at 12 weeks or end of study | Changes in laboratory analytes will be classified as normal or abnormal (example: white blood cell counts) |
| Vital Signs - Temperature | Baseline and 12 weeks or end of study | Clinically significant changes in Temperature will be assessed for normal or abnormal following randomization to 12 weeks or end of study. |
| Vital Signs - Blood Pressure Systolic and Diastolic | Baseline and 12 weeks or end of study | Clinically significant changes in BP will be assessed for normal or abnormal following randomization to 12 weeks or end of study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sensoril® Sensoril® is a proprietary extract of Withania Somnifera
Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera | 34 |
| Placebo Placebo
Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules. | 34 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Patient did not take study medication | 1 | 1 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Sensoril® | Total |
|---|---|---|---|
| Age at onset of 1st episode | 24.00 years STANDARD_DEVIATION 7.67 | 24.32 years STANDARD_DEVIATION 10.89 | 24.16 years STANDARD_DEVIATION 9.35 |
| Age, Continuous | 47.38 years STANDARD_DEVIATION 11.37 | 45.18 years STANDARD_DEVIATION 12.9 | 46.28 years STANDARD_DEVIATION 12.12 |
| Current Smokers | 19 Participants | 22 Participants | 41 Participants |
| Diagnosis Schizophrenia or Schizoaffective Diagnosis Schizoaffective | 16 Participants | 13 Participants | 29 Participants |
| Diagnosis Schizophrenia or Schizoaffective Diagnosis Schizophrenia | 18 Participants | 21 Participants | 39 Participants |
| Number of lifetime psychiatric hospitalizations | 7.76 psychiatric hospitalizations STANDARD_DEVIATION 6.9 | 7.71 psychiatric hospitalizations STANDARD_DEVIATION 6.45 | 7.74 psychiatric hospitalizations STANDARD_DEVIATION 6.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 22 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 20 Participants | 12 Participants | 32 Participants |
| Region of Enrollment United States | 34 Participants | 34 Participants | 68 Participants |
| Sex: Female, Male Female | 20 Participants | 13 Participants | 33 Participants |
| Sex: Female, Male Male | 14 Participants | 21 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 24 / 33 | 20 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Positive and Negative Syndrome Scale (PANSS)
The Positive and Negative Syndrome Scale (PANSS) measures symptom severity in patients with psychotic illnesses. It yields a total score as well as subscores for Positive symptoms, Negative symptoms and General symptoms. PANSS Positive subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome. PANSS Negative subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome. General Psychopathology subscale consists of 16 items - (minimum score = 16, maximum score = 112) - Higher values represent a worse outcome. PANSS Total Score - The 3 subscales scores are summed to compute a PANSS Total score. The minimum PANSS total score = 30, maximum = 210 - Higher values represent a worse outcome
Time frame: Baseline and 12 Weeks
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Positive and Negative Syndrome Scale (PANSS) | PANSS Positive Baseline | 19.58 units on a scale | Standard Deviation 3.34 |
| Sensoril® | Positive and Negative Syndrome Scale (PANSS) | PANSS Positive at 12 weeks | 14.39 units on a scale | Standard Deviation 3.94 |
| Sensoril® | Positive and Negative Syndrome Scale (PANSS) | PANSS Negative Baselin | 16.52 units on a scale | Standard Deviation 4.52 |
| Sensoril® | Positive and Negative Syndrome Scale (PANSS) | PANSS Negative at 12 weeks | 12.97 units on a scale | Standard Deviation 4.46 |
| Sensoril® | Positive and Negative Syndrome Scale (PANSS) | PANSS General Baseline | 33.79 units on a scale | Standard Deviation 5.04 |
| Sensoril® | Positive and Negative Syndrome Scale (PANSS) | PANSS General at 12 weeks | 26.55 units on a scale | Standard Deviation 4.99 |
| Sensoril® | Positive and Negative Syndrome Scale (PANSS) | PANSS Total at Baseline | 69.88 units on a scale | Standard Deviation 8 |
| Sensoril® | Positive and Negative Syndrome Scale (PANSS) | PANSS total at 12 weeks | 53.91 units on a scale | Standard Deviation 11.4 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) | PANSS total at 12 weeks | 61.48 units on a scale | Standard Deviation 14.89 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) | PANSS Positive Baseline | 19.97 units on a scale | Standard Deviation 2.57 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) | PANSS General Baseline | 33.24 units on a scale | Standard Deviation 5.27 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) | PANSS Positive at 12 weeks | 15.33 units on a scale | Standard Deviation 4.75 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) | PANSS Total at Baseline | 69.48 units on a scale | Standard Deviation 8.45 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) | PANSS Negative Baselin | 17.27 units on a scale | Standard Deviation 5.25 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) | PANSS General at 12 weeks | 30.27 units on a scale | Standard Deviation 7.45 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) | PANSS Negative at 12 weeks | 15.88 units on a scale | Standard Deviation 5.75 |
Secondary
Clinical Global Impression Scale (CGI-S) - Severity
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 0 = not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients - The higher the score the worse outcome
Time frame: Baseline and 12 weeks or end of study
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Clinical Global Impression Scale (CGI-S) - Severity | CGI Severity score at baseline | 4.06 units on a scale | Standard Deviation 0.24 |
| Sensoril® | Clinical Global Impression Scale (CGI-S) - Severity | CGI Severity score at 12 weeks | 3.88 units on a scale | Standard Deviation 0.49 |
| Placebo | Clinical Global Impression Scale (CGI-S) - Severity | CGI Severity score at baseline | 4.09 units on a scale | Standard Deviation 0.38 |
| Placebo | Clinical Global Impression Scale (CGI-S) - Severity | CGI Severity score at 12 weeks | 3.97 units on a scale | Standard Deviation 0.47 |
Secondary
Immune Marker Hs-CRP (High Sensitivity C Reactive Protein)
Changes in immune marker hs-CRP (high sensitivity C Reactive Protein) will be assessed in response to study medication. hsCRP - mg/L
Time frame: Baseline and 12 weeks or end of study
Population: The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for hs-CRP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Immune Marker Hs-CRP (High Sensitivity C Reactive Protein) | Pre Rx | 5.57 mg/L | Standard Deviation 8.57 |
| Sensoril® | Immune Marker Hs-CRP (High Sensitivity C Reactive Protein) | End of Rx | 4.49 mg/L | Standard Deviation 5.09 |
| Placebo | Immune Marker Hs-CRP (High Sensitivity C Reactive Protein) | Pre Rx | 6.27 mg/L | Standard Deviation 6.9 |
| Placebo | Immune Marker Hs-CRP (High Sensitivity C Reactive Protein) | End of Rx | 7.82 mg/L | Standard Deviation 8.25 |
Secondary
Immune Marker IFN-Y (Gamma)
Changes in immune marker IFN-Y (gamma) will be assessed in response to study medication.
Time frame: Baseline and 12 weeks or end of study
Population: data cannot be summarized IFN-Y (gamma) levels undetectable
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sensoril® | Immune Marker IFN-Y (Gamma) | NA pg/mL |
| Placebo | Immune Marker IFN-Y (Gamma) | NA pg/mL |
Secondary
Immune Marker IL-2
Changes in immune marker IL-2 will be assessed in response to study medication.
Time frame: Baseline and 12 weeks or end of study
Population: IL-2 levels undetectable.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sensoril® | Immune Marker IL-2 | NA pg/mL |
| Placebo | Immune Marker IL-2 | NA pg/mL |
Secondary
Immune Marker IL-4
Changes in immune marker IL-4 will be assessed in response to study medication.
Time frame: Baseline and12 weeks or end of study
Population: Data cannot be summarized- IL-4 levels undetectable
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sensoril® | Immune Marker IL-4 | NA pg/mL |
| Placebo | Immune Marker IL-4 | NA pg/mL |
Secondary
Immune Marker IL-6
Changes in immune marker IL-6 will be assessed in response to study medication.
Time frame: Changes from Baseline in Immune markers at 12 weeks or end of study
Population: The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for IL-6.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Immune Marker IL-6 | IL6 level at baseline | 3.37 pg/mL | Standard Deviation 2.53 |
| Sensoril® | Immune Marker IL-6 | IL 6 level at end of treatment | 3.40 pg/mL | Standard Deviation 2.51 |
| Placebo | Immune Marker IL-6 | IL6 level at baseline | 4.29 pg/mL | Standard Deviation 3.34 |
| Placebo | Immune Marker IL-6 | IL 6 level at end of treatment | 3.87 pg/mL | Standard Deviation 2.57 |
Secondary
Immune Marker S-100B
Changes in immune marker S-100B will be assessed in response to study medication. Elisa * Sensitivity 2.7 picogm/ml * Range 2.7 to 2000 picogm/ml
Time frame: Baseline and 12 weeks or end of treatment
Population: The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for S-100B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Immune Marker S-100B | S100B pre Rx | 39.36 pg/mL | Standard Deviation 89.92 |
| Sensoril® | Immune Marker S-100B | S100B end of Rx | 26.38 pg/mL | Standard Deviation 79.44 |
| Placebo | Immune Marker S-100B | S100B pre Rx | 34.95 pg/mL | Standard Deviation 56.12 |
| Placebo | Immune Marker S-100B | S100B end of Rx | 62.49 pg/mL | Standard Deviation 173.92 |
Secondary
Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: Possible ratings are: 1= Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5= Minimally worse, 6= Much worse, 7=Very much worse. The higher the score the worse outcome
Time frame: 12 weeks
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sensoril® | Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale | 12 Participants |
| Placebo | Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale | 8 Participants |
Secondary
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) was developed to measure the degree to which situations in one's life are appraised as stressful. Perceived Stress Scale Scoring Each item is rated on a 5-point scale ranging from never (0) to very often (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress. PSS-10 scores are obtained by reversing the scores on the four positive items: For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Total score can range from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress,
Time frame: Baseline and 12 weeks or end of treatment
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Perceived Stress Scale (PSS) | PSS score at Baseline | 22.48 units on a scale | Standard Deviation 7.27 |
| Sensoril® | Perceived Stress Scale (PSS) | PSS score at 12 weeks | 14.67 units on a scale | Standard Deviation 5.87 |
| Placebo | Perceived Stress Scale (PSS) | PSS score at Baseline | 20.55 units on a scale | Standard Deviation 6.68 |
| Placebo | Perceived Stress Scale (PSS) | PSS score at 12 weeks | 18.09 units on a scale | Standard Deviation 6.64 |
Other Pre-specified
Laboratory Analytes
Changes in laboratory analytes will be classified as normal or abnormal (example: white blood cell counts)
Time frame: Change from Baseline in Laboratory Analytes at 12 weeks or end of study
Other Pre-specified
Vital Signs - Blood Pressure Systolic and Diastolic
Clinically significant changes in BP will be assessed for normal or abnormal following randomization to 12 weeks or end of study.
Time frame: Baseline and 12 weeks or end of study
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Vital Signs - Blood Pressure Systolic and Diastolic | Systolic BP at baseline | 124.67 mm/Hg | Standard Deviation 10.53 |
| Sensoril® | Vital Signs - Blood Pressure Systolic and Diastolic | Systolic BP at end of treatment | 123.36 mm/Hg | Standard Deviation 9.3 |
| Sensoril® | Vital Signs - Blood Pressure Systolic and Diastolic | Diastolic BP at baseline | 79.15 mm/Hg | Standard Deviation 7.95 |
| Sensoril® | Vital Signs - Blood Pressure Systolic and Diastolic | Diastolic BP at end of treatment | 79.06 mm/Hg | Standard Deviation 7.31 |
| Placebo | Vital Signs - Blood Pressure Systolic and Diastolic | Diastolic BP at end of treatment | 75.55 mm/Hg | Standard Deviation 13.21 |
| Placebo | Vital Signs - Blood Pressure Systolic and Diastolic | Systolic BP at baseline | 123.42 mm/Hg | Standard Deviation 15.32 |
| Placebo | Vital Signs - Blood Pressure Systolic and Diastolic | Diastolic BP at baseline | 76.52 mm/Hg | Standard Deviation 11.52 |
| Placebo | Vital Signs - Blood Pressure Systolic and Diastolic | Systolic BP at end of treatment | 118.39 mm/Hg | Standard Deviation 23.19 |
Other Pre-specified
Vital Signs - Body Mass Index
Clinically significant changes in BMI will be assessed for normal or abnormal following randomization to 12 weeks or end of study.
Time frame: Baseline and 12 weeks or end of study
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Vital Signs - Body Mass Index | BMI at baseline | 30.00 kg/m^2 | Standard Deviation 7.56 |
| Sensoril® | Vital Signs - Body Mass Index | BMI at end of treatment | 30.33 kg/m^2 | Standard Deviation 8.04 |
| Placebo | Vital Signs - Body Mass Index | BMI at baseline | 30.36 kg/m^2 | Standard Deviation 6.35 |
| Placebo | Vital Signs - Body Mass Index | BMI at end of treatment | 30.56 kg/m^2 | Standard Deviation 6.24 |
Other Pre-specified
Vital Signs - Pulse
Clinically significant changes in Pulse will be assessed for normal or abnormal following randomization to 12 weeks or end of study.
Time frame: Baseline and 12 weeks or end of study
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Vital Signs - Pulse | Pulse at baseline | 76.18 beats/min | Standard Deviation 13.38 |
| Sensoril® | Vital Signs - Pulse | Pulse at end of treatment | 75.42 beats/min | Standard Deviation 14.64 |
| Placebo | Vital Signs - Pulse | Pulse at end of treatment | 76.42 beats/min | Standard Deviation 9.56 |
| Placebo | Vital Signs - Pulse | Pulse at baseline | 74.91 beats/min | Standard Deviation 11.75 |
Other Pre-specified
Vital Signs - Temperature
Clinically significant changes in Temperature will be assessed for normal or abnormal following randomization to 12 weeks or end of study.
Time frame: Baseline and 12 weeks or end of study
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Vital Signs - Temperature | Temperature at baseline | 97.38 degrees F | Standard Deviation 0.57 |
| Sensoril® | Vital Signs - Temperature | Temperature at end of treatment | 97.37 degrees F | Standard Deviation 0.73 |
| Placebo | Vital Signs - Temperature | Temperature at baseline | 97.36 degrees F | Standard Deviation 0.72 |
| Placebo | Vital Signs - Temperature | Temperature at end of treatment | 97.31 degrees F | Standard Deviation 0.46 |
Other Pre-specified
Vital Signs - Weight
Clinically significant changes in weight will be assessed for normal or abnormal following randomization to 12 weeks or end of study
Time frame: Baseline and 12 weeks or end of study
Population: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensoril® | Vital Signs - Weight | Body Weight at baseline | 194.61 lbs | Standard Deviation 49.57 |
| Sensoril® | Vital Signs - Weight | Body Weight at end of Rx | 197.00 lbs | Standard Deviation 51.94 |
| Placebo | Vital Signs - Weight | Body Weight at baseline | 191.33 lbs | Standard Deviation 41.29 |
| Placebo | Vital Signs - Weight | Body Weight at end of Rx | 193.06 lbs | Standard Deviation 41.33 |