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

Phase 2

Terminated

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).

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Withania Somnifera Extract (WSE)	WSE	WSE 500 mg bid for 12 weeks
Placebo tablets	Placebo Oral Tablet	Placebo oral tablet bid for 12 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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