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Ashwagandha for Schizophrenia
Phase 2 & 3
Waitlist Available
Research Sponsored by Chengappa, K.N. Roy, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of a positive symptom exacerbation during the year prior to study entry.
Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or schizoaffective disorder
Must not have
Currently receiving immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDS associated drugs).
Currently receiving antibiotics, anti-viral, or anti-parasitic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing if a plant extract called Ashwagandha can help people with schizophrenia by reducing their symptoms and stress levels. Ashwagandha, also known as Withania somnifera, has traditionally been used in Ayurvedic medicine and has shown potential in treating psychiatric disorders, including schizophrenia.
Who is the study for?
This trial is for adults with schizophrenia or schizoaffective disorder, who have had a recent symptom exacerbation and score high on specific psychopathology scales. Women must not be pregnant or breastfeeding and should test negative for pregnancy. Participants must not be using certain drugs like immunosuppressants, undergoing addiction treatment (case by case), or have serious unstable illnesses.
What is being tested?
The study tests if Withania somnifera extract (WSE) can lower psychopathology scores in people with schizophrenia compared to a placebo. It looks at the overall impact on mental health symptoms as well as stress levels measured by the Perceived Stress Scale.
What are the potential side effects?
Potential side effects of WSE are not detailed here but may include allergic reactions based on past adverse events noted in individuals with known allergy to WSE. As it's an herbal supplement, other side effects could vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms have worsened in the past year.
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on medication that suppresses my immune system.
Select...
I am currently taking antibiotics, anti-viral, or anti-parasitic medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Positive and Negative Symptom Scale
Secondary study objectives
PANSS Negative Factor Score Also Know as Marder Factors
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Withania Somnifera Extract (WSE)Experimental Treatment1 Intervention
WSE 500 mg bid for 12 weeks
Group II: Placebo tabletsPlacebo Group1 Intervention
Placebo oral tablet bid for 12 weeks
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for schizophrenia primarily target neurotransmitter systems, especially dopamine and serotonin. Antipsychotic medications work by blocking dopamine receptors to reduce psychotic symptoms like hallucinations and delusions, while atypical antipsychotics also affect serotonin receptors to help with mood and cognitive symptoms.
Adaptogenic treatments such as Withania somnifera (Ashwagandha) are being explored for their potential to modulate neurotransmitter systems and reduce stress, which could benefit schizophrenia patients by addressing both core symptoms and stress-related issues.
Memantine as an Augmentation Treatment for Schizophrenia: Limitations of Meta-Analysis for Evidence-Based Evaluation of Research.[Diagnosis and treatment of motor phenomena in schizophrenia spectrum disorders].Dosing atypical antipsychotics.
Memantine as an Augmentation Treatment for Schizophrenia: Limitations of Meta-Analysis for Evidence-Based Evaluation of Research.[Diagnosis and treatment of motor phenomena in schizophrenia spectrum disorders].Dosing atypical antipsychotics.
Find a Location
Who is running the clinical trial?
University of MarylandOTHER
166 Previous Clinical Trials
304,650 Total Patients Enrolled
9 Trials studying Schizophrenia
871 Patients Enrolled for Schizophrenia
Chengappa, K.N. Roy, MDLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Maryland Psychiatric Research CenterUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not tested positive for illicit drugs, except possibly for marijuana or opioids.My symptoms have worsened in the past year.I am currently on medication that suppresses my immune system.I am currently taking antibiotics, anti-viral, or anti-parasitic medications.You are pregnant or currently breastfeeding.You have severe and unstable medical conditions.I have been diagnosed with schizophrenia or schizoaffective disorder.You have behavior that makes it likely that you may need to be hospitalized soon, such as being suicidal or aggressive.I am on medication for addiction, which will need review.You have had a serious allergic reaction or bad experience with WSE in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo tablets
- Group 2: Withania Somnifera Extract (WSE)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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