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

Inclusion Criteria:

- Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or
schizoaffective disorder

- Ability to provide informed written consent

- PANSS total score ≥ 70 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.

- Receiving anti-psychotic medications for ≥ 4 weeks

- 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).