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Trial record 78 of 3313 for:    schizophrenia

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

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ClinicalTrials.gov Identifier: NCT03437668
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Stanley Medical Research Institute
University of Maryland, College Park
Information provided by (Responsible Party):
Stephen Marder, University of California, Los Angeles

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).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: WSE Drug: Placebo Oral Tablet Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Withania Somnifera Extract (WSE)
WSE 500 mg bid for 12 weeks
Drug: WSE
WSE tablets
Other Names:
  • Withania somnifera extracts
  • Ashwagandha
  • Sensoril®

Placebo Comparator: Placebo tablets
Placebo oral tablet bid for 12 weeks
Drug: Placebo Oral Tablet
Placebo tablet




Primary Outcome Measures :
  1. Positive and Negative Symptom Scale [ Time Frame: 12 weeks ]
    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. A patient cannot score lower than 30 for the total PANSS score. Scores are often given separately for the positive items, negative items, and general psychopathology.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or schizoaffective disorder
  • Ability to provide informed written consent
  • PANSS total score ≥ 70 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.
  • Receiving anti-psychotic medications for ≥ 4 weeks
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437668


Contacts
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Contact: Stephen R Marder, MD 310-268-4359 ext 013102684359 marder@ucla.edu
Contact: Robert W Buchanan, MD 410-402-7876 ext 013102684359 rwbuchanan@mprc.umaryland.edu

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90272
Contact: Gerard DeVera    310-794-5577 ext 3104865955    Gdevera@mednet.ucla.edu   
Contact: Claudia Vera    310-794-5577 ext 3104865955    cavera@mednet.ucla.edu   
Principal Investigator: Stephen Marder, MD         
United States, Maryland
Maryland Psychiatric Research Center Recruiting
Catonsville, Maryland, United States, 21228
Contact: Jennifer Zaranski    410-402-6060    jzaranski@som.umaryland.edu   
Principal Investigator: Robert W Buchanan, MD         
Sponsors and Collaborators
Chengappa, K.N. Roy, MD
Stanley Medical Research Institute
University of Maryland, College Park
Investigators
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Study Chair: Stephen Marder, MD Semel Inst at UCLA

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Responsible Party: Stephen Marder, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03437668     History of Changes
Other Study ID Numbers: PRO18030276
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Deidentified will be submitted an NIH repository

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephen Marder, University of California, Los Angeles:
Schizophrenia
Withania Somnifera
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders