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

NCT03437668 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO18030276
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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).

Conditions

Schizophrenia

Keywords

Schizophrenia; Withania Somnifera

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PANSS Negative Factor Score Also Know as Marder Factors

  12 weeks

Study Arms (2)

Withania Somnifera Extract (WSE)

EXPERIMENTAL

WSE 500 mg bid for 12 weeks

Drug: WSE

Placebo tablets

PLACEBO COMPARATOR

Placebo oral tablet bid for 12 weeks

Drug: Placebo Oral Tablet

Interventions

WSE DRUG

WSE tablets

Also known as: Withania somnifera extracts, Ashwagandha, Sensoril®

Withania Somnifera Extract (WSE)

Placebo Oral Tablet DRUG

Placebo tablet

Placebo tablets

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify 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).

Sponsors & Collaborators

• Chengappa, K.N. Roy, MD: lead
• Stanley Medical Research Institute: collaborator
• University of Maryland: collaborator

Study Sites (2)

UCLA

Los Angeles, California, 90095, United States

Location

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Ashwagandha

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Stephen R Marder
• Organization: UCaliforniaLA

smarder@mednet.ucla.edu

3102670221

Study Officials

• Stephen Marder, MD

  Semel Inst at UCLA

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 19, 2018
• Study Start: December 1, 2018
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Locations

US (2)