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

Primary Purpose

Schizophrenia

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

WSE

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Withania Somnifera

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

UCLA
Maryland Psychiatric Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Withania Somnifera Extract (WSE)

Placebo tablets

Arm Description

WSE 500 mg bid for 12 weeks

Placebo oral tablet bid for 12 weeks

Outcomes

Primary Outcome Measures

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. 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03437668

First Posted

February 1, 2018

Last Updated

July 5, 2023

Sponsor

Chengappa, K.N. Roy, MD

Collaborators

Stanley Medical Research Institute, Maryland Psychiatric Research Center

1. Study Identification

Unique Protocol Identification Number

NCT03437668

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

June 30, 2023 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chengappa, K.N. Roy, MD

Collaborators

Stanley Medical Research Institute, Maryland Psychiatric Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, Withania Somnifera

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Withania Somnifera Extract (WSE)

Arm Type

Experimental

Arm Description

WSE 500 mg bid for 12 weeks

Arm Title

Placebo tablets

Arm Type

Placebo Comparator

Arm Description

Placebo oral tablet bid for 12 weeks

Intervention Type

Drug

Intervention Name(s)

WSE

Other Intervention Name(s)

Withania somnifera extracts, Ashwagandha, Sensoril®

Intervention Description

WSE tablets

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

Placebo tablet

Primary Outcome Measure Information:

Title

Positive and Negative Symptom Scale

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Marder, MD

Organizational Affiliation

Semel Inst at UCLA

Official's Role

Study Chair

Facility Information:

Facility Name

UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Maryland Psychiatric Research Center

City

Catonsville

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Deidentified will be submitted an NIH repository

Learn more about this trial

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

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