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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03437668
• Other study ID #: PRO18030276
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• WSE
WSE tablets
• Placebo Oral Tablet
Placebo tablet

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center	Catonsville	Maryland
United States	UCLA	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Chengappa, K.N. Roy, MD	Maryland Psychiatric Research Center, Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks