Ashwagandha for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Ashwagandha, a plant-based supplement, can reduce symptoms in people with schizophrenia or schizoaffective disorder. The main goal is to determine if Ashwagandha can lower overall mental health symptoms and stress levels. Participants will take either Ashwagandha or a placebo (a dummy pill) for 12 weeks. This trial suits those diagnosed with schizophrenia or schizoaffective disorder who have experienced worsening symptoms in the past year. As a Phase 2 and Phase 3 trial, the research measures Ashwagandha's effectiveness in a larger group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Withania somnifera, also known as Ashwagandha, is generally safe for use. In studies where Ashwagandha supplemented regular medications for patients with schizophrenia, it proved safe and did not cause major side effects. It also helped reduce schizophrenia symptoms.
Other studies have examined Ashwagandha for issues like anxiety, stress, and memory problems. These studies also found Ashwagandha to be safe and well-tolerated, with no serious harmful effects reported.
In summary, current research suggests that Ashwagandha is safe for people, including those with schizophrenia.12345Why do researchers think this study treatment might be promising for schizophrenia?
Researchers are excited about Withania Somnifera, commonly known as Ashwagandha, for schizophrenia because it offers a natural alternative to conventional antipsychotic medications. Unlike standard treatments like risperidone or olanzapine, which often come with a host of side effects, Ashwagandha is derived from a plant traditionally used in Ayurvedic medicine and is known for its adaptogenic properties. It potentially targets oxidative stress and inflammation, which may play roles in schizophrenia, offering a novel mechanism of action. This could mean fewer side effects and a more holistic approach to managing symptoms, sparking interest in both the scientific and medical communities.
What evidence suggests that Withania Somnifera might be an effective treatment for schizophrenia?
Research shows that Withania somnifera, commonly known as ashwagandha, might help reduce symptoms in people with schizophrenia. Studies have found that it can improve depression and anxiety, often experienced by those with schizophrenia. One study found that it may help with symptoms that have recently worsened. In this trial, participants will receive either Withania somnifera extract or placebo tablets. Most research suggests positive effects when ashwagandha is used along with other treatments. These findings indicate it could be a promising addition to managing schizophrenia symptoms.16789
Who Is on the Research Team?
Stephen Marder, MD
Principal Investigator
Semel Inst at UCLA
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Withania Somnifera Extract or placebo for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Withania Somnifera (Ashwagandha)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chengappa, K.N. Roy, MD
Lead Sponsor
University of Maryland
Collaborator
Maryland Psychiatric Research Center
Collaborator
Stanley Medical Research Institute
Collaborator