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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chengappa, K.N. Roy, MD; University of California, Los Angeles
• Collaborators: Stanley Medical Research Institute; University of Maryland; University of Maryland, College Park

Criteria

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).