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

About

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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
64 Years

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).

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Study Stats
Protocol No.
18-000060
Category
Semel Institute (Psychiatry)
Principal Investigator
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03437668
For detailed technical eligibility, visit ClinicalTrials.gov.