Status:
TERMINATED
Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
Lead Sponsor:
Chengappa, K.N. Roy, MD
Collaborating Sponsors:
Stanley Medical Research Institute
University of Maryland
Conditions:
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
PHASE3
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 redu...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03437668
Start Date
December 1 2018
End Date
June 12 2023
Last Update
October 8 2024
Active Locations (2)
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1
UCLA
Los Angeles, California, United States, 90095
2
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228