Ashwagandha for Schizophrenia

Recruiting at 1 trial location

Overseen By Stephen R Marder, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Chengappa, K.N. Roy, MD

Must not be taking: Antibiotics, Antivirals, Immunosuppressants, others

Disqualifiers: Substance abuse, Pregnancy, Unstable illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

47 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking antibiotics, anti-viral, anti-parasitic, and immunosuppressive medications. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Ashwagandha for treating schizophrenia?

Research suggests that Ashwagandha, when used alongside other treatments, may help reduce symptoms of depression and anxiety in people with schizophrenia. It is also known for its anti-inflammatory properties, which might help improve overall mental health in these patients. ^{1 2 3 4 5}

Is Ashwagandha safe for use in humans?

Ashwagandha, also known as Withania somnifera, is generally considered safe for human use, with minimal side effects reported in studies. However, high doses may cause moderate to severe toxic effects, so it's important to use it within recommended limits. ^{1 2 3 6 7}

How does Ashwagandha differ from other treatments for schizophrenia?

Ashwagandha is unique because it is a natural herb traditionally used in Ayurvedic medicine, known for its adaptogenic properties, which means it helps the body manage stress. Unlike standard antipsychotic medications, Ashwagandha may also help reduce symptoms of anxiety and depression in people with schizophrenia, offering a more holistic approach to treatment. ^{1 3 8 9 10}

Research Team

Stephen Marder, MD

Principal Investigator

Semel Inst at UCLA

Eligibility Criteria

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.

Inclusion Criteria

Ability to provide informed written consent

My symptoms have worsened in the past year.

For women of child bearing age, a negative serum pregnancy test at screening

Exclusion Criteria

I have not tested positive for illicit drugs, except possibly for marijuana or opioids.

I am currently on medication that suppresses my immune system.

I am currently taking antibiotics, anti-viral, or anti-parasitic medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Withania Somnifera Extract or placebo for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Withania Somnifera (Ashwagandha)

Trial Overview 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.

Participant Groups

Group I: Withania Somnifera Extract (WSE) Experimental Treatment 1 Intervention

WSE 500 mg bid for 12 weeks

Group II: Placebo tablets Placebo Group 1 Intervention

Placebo oral tablet bid for 12 weeks

Who Is Running the Clinical Trial?

Chengappa, K.N. Roy, MD

Lead Sponsor

Trials

2

Recruited

80+

University of Maryland

Collaborator

Trials

171

Recruited

325,000+

Maryland Psychiatric Research Center

Collaborator

Trials

1

Recruited

50+

Stanley Medical Research Institute

Collaborator

Trials

141

Recruited

10,400+

Findings from Research

A systematic review of five human trials found that Withania somnifera (ashwagandha) significantly reduced anxiety and stress levels compared to placebo, with notable improvements in scores on the Hamilton Anxiety Scale and Perceived Stress Scale.

Despite the positive findings, the studies had high risks of bias and varied methodologies, suggesting that while ashwagandha shows promise as an anxiety treatment, further research is needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An alternative treatment for anxiety: a systematic review of human trial results reported for the Ayurvedic herb ashwagandha (Withania somnifera). Pratte, MA., Nanavati, KB., Young, V., et al.[2018]

A systematic review of five clinical studies suggests that Withania somnifera (Ashwagandha) may improve cognitive function in various populations, including older adults with mild cognitive impairment and individuals with mental health disorders.

The studies indicate that Ashwagandha supplementation is well tolerated, showing good adherence and minimal side effects, making it a promising option for managing cognitive dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical use of Withania somnifera (Ashwagandha) to ameliorate cognitive dysfunction. Ng, QX., Loke, W., Foo, NX., et al.[2020]

Withania somnifera, or Ashwagandha, is recognized for its potential benefits in promoting physical and mental health, particularly in treating various central nervous system disorders such as epilepsy, stress, and neurodegenerative diseases like Parkinson's and Alzheimer's.

The review highlights Ashwagandha's broad pharmacological activity, suggesting it may help rejuvenate the body and improve health in debilitated conditions, making it a valuable herb in traditional Ayurvedic medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Withania somnifera: an Indian ginseng. Kulkarni, SK., Dhir, A.[2022]

The study assessed the genetic diversity of 9 different ashwagandha cultivars using 20 ISSR primers, revealing that 86.1% of the genetic markers were polymorphic, indicating significant genetic variation among the varieties.

The findings suggest that ISSR molecular diversity assessments can help identify phylogenetic relationships among ashwagandha genotypes, which could be used to develop high-yielding varieties and improve desirable traits in this medicinal plant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular characterization of India Ginseng Withania somnifera (L) using ISSR markers. Hiremath, C., Philip, R., Sundaresan, V.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a standardized extract of Withania somnifera (Ashwagandha) on depression and anxiety symptoms in persons with schizophrenia participating in a randomized, placebo-controlled clinical trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Adjunctive Use of a Standardized Extract of Withania somnifera (Ashwagandha) to Treat Symptom Exacerbation in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

An alternative treatment for anxiety: a systematic review of human trial results reported for the Ayurvedic herb ashwagandha (Withania somnifera). [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Add-on effect of Brahmi in the management of schizophrenia. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Sub-acute toxicity of Ashwagandha (Withania somnifera) root extract in wistar rats. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A critical assessment of the whole plant-based phytotherapeutics from Withania somnifera (L.) Dunal with respect to safety and efficacy vis-a-vis leaf or root extract-based formulation. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical use of Withania somnifera (Ashwagandha) to ameliorate cognitive dysfunction. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Withania somnifera: an Indian ginseng. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Molecular characterization of India Ginseng Withania somnifera (L) using ISSR markers. [2021]

10. India pubmed.ncbi.nlm.nih.gov

Allelopathic effect of Ashwagandha against the germination and radicle growth of Cicer arietinum and Triticum aestivum. [2021]