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

NCT ID: NCT03437668

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2023-06-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Withania Somnifera Extract (WSE)

WSE 500 mg bid for 12 weeks

Group Type: EXPERIMENTAL

WSE

Intervention Type: DRUG

WSE tablets

Placebo tablets

Placebo oral tablet bid for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo tablet

Interventions

WSE

WSE tablets

Intervention Type: DRUG

Placebo Oral Tablet

Placebo tablet

Intervention Type: DRUG

Other Intervention Names

Withania somnifera extracts; Ashwagandha; Sensoril®

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

Chengappa, K.N. Roy, MD

OTHER

Sponsor Role: lead

Responsible Party

Stephen Marder

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Marder, MD

Role: STUDY_CHAIR

Semel Inst at UCLA

Locations

UCLA

Los Angeles, California, United States

Maryland Psychiatric Research Center

Catonsville, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO18030276

Identifier Type: -

Identifier Source: org_study_id