Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia

Study Overview
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Brief Summary
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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).

Official Title
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Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: WSE
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Withania Somnifera Extract (WSE)<br>WSE 500 mg bid for 12 weeks | Drug: WSE<br>* WSE tablets<br>* Other names: Sensoril®;|
| Placebo Comparator: Placebo tablets<br>Placebo oral tablet bid for 12 weeks | Drug: Placebo Oral Tablet<br>* Placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. A patient cannot score lower than 30 for the total PANSS score. Scores are often given separately for the positive items, negative items, and general psychopathology. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Withania Somnifera, Schizophrenia