What side effects are associated with this type of intervention?

Common treatments for schizophrenia include second-generation antipsychotics such as aripiprazole and risperidone, which are preferred due to their relatively favorable side effect profiles compared to first-generation antipsychotics. However, they can still cause side effects such as weight gain, metabolic syndrome, and sedation. First-generation antipsychotics like haloperidol are associated with a higher risk of extrapyramidal symptoms (EPS) such as akathisia, dystonia, and parkinsonism. Adaptogenic treatments like Withania somnifera are being studied for their potential to reduce stress and modulate neurotransmitters, but their side effects are not yet well-documented in the context of schizophrenia treatment.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, primarily focusing on neurotransmitter modulation. These include atypical antipsychotics like olanzapine, risperidone, and quetiapine, which target dopamine and serotonin receptors to manage symptoms. While Withania somnifera (Ashwagandha) is being studied for its adaptogenic properties and potential to modulate neurotransmitters, it is not yet FDA-approved for schizophrenia. Current FDA-approved treatments do not typically include adaptogenic herbs but focus on pharmacological agents that directly influence neurotransmitter pathways.

What other types of research exist?

Promising novel alternatives to Withania somnifera extract for schizophrenia patients include cannabidiol (CBD), which has shown potential in reducing psychotic symptoms, and N-acetylcysteine (NAC), which may help with glutamate modulation and oxidative stress. Additionally, omega-3 fatty acids have been studied for their anti-inflammatory and neuroprotective effects. These alternatives should be discussed with a healthcare provider to tailor treatment to individual needs.

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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 below

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My symptoms have worsened in the past year.

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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:

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I am currently on medication that suppresses my immune system.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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

0 / 4Eligibility criteria met

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.