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

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).

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: WSE; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Withania Somnifera Extract (WSE); WSE 500 mg bid for 12 weeks	Drug: WSE; WSE tablets; Other Names: Ashwagandha; Withania somnifera extracts; Sensoril®
Placebo Comparator: Placebo tablets; Placebo oral tablet bid for 12 weeks	Drug: Placebo Oral Tablet; Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Symptom Scale	The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Subjects can not score lower than 30 or higher than 210. Higher score indicates higher amount of psychopathology	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PANSS Negative Factor Score Also Know as Marder Factors	The Marder negative factor is a factor-analysis derived dimension of the Positive and Negative Syndrome Scale (PANSS) that measures negative symptoms of schizophrenia. It's made up of seven items from the PANSS, including: Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic withdrawal, Motor retardation, Active social avoidance, Lack of spontaneity in conversation. Each item is scored from 1 to 7 with a higher score indicating greater severity. Minimum score is 7 and maximum is 49	12 weeks

Collaborators and Investigators

• Sponsor: Chengappa, K.N. Roy, MD
• Collaborators: University of Maryland; Stanley Medical Research Institute
• Investigators: Study Chair: Stephen Marder, MD, Semel Inst at UCLA

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Withania Somnifera
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: PRO18030276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified will be submitted an NIH repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No