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

Inclusion Criteria:

• Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia orschizoaffective disorder

• Ability to provide informed written consent

• PANSS total score ≥ 70 or a CGI Severity Scored ≥ 4; and at least 2 positive symptomsubscale items (i.e., delusions, conceptual disorganization, hallucinatory behavior,excitement, grandiosity, suspiciousness/persecution, hostility and unusual thoughtcontent) 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 beassessed on a case by case basis due to the long elimination half life in the urineof marijuana and the use of opioids for various pain disorders, caffeine andnicotine 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 aggressivebehavior)

• Currently receiving antibiotics, anti-viral, or anti-parasitic medications

• Currently receiving immunosuppressive medications (e.g. oral scheduledcorticosteroids, chemotherapy or transplantation or HIV/AIDS associated drugs).