Summary

Eligibility
for people ages 18-64 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Stephen Marder, MD (ucla)

Description

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).

Keywords

Schizophrenia, Withania Somnifera, WSE, Withania Somnifera Extract (WSE)

Eligibility

You can join if…

Open to people ages 18-64

  • 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

You CAN'T join if...

  • 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).

Locations

  • UCLA
    Los Angeles California 90095 United States
  • Maryland Psychiatric Research Center
    Catonsville Maryland 21228 United States

Lead Scientist at University of California Health

  • Stephen Marder, MD (ucla)
    Dr. Stephen Marder holds the Dr. Daniel X. Freedman Administrative Chair in Academic Psychiatry.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Chengappa, K.N. Roy, MD
ID
NCT03437668
Phase
Phase 2/3 Schizophrenia Research Study
Study Type
Interventional
Participants
Expecting 66 study participants
Last Updated