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

Chengappa, K.N. Roy, MD

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Schizophrenia

Treatments

Drug: WSE

Drug: Placebo Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT03437668

PRO18030276

Details and patient eligibility

About

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).

Enrollment

47 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No 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).