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

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

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).

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).