Withania somnifera (Ashwagandha) as an Adjunctive Treatment to Antipsychotic Medications for Patients With Schizophrenia

OBJECTIVE: To evaluate the effects of Withania somnifera extract (WSE), or Ashwagandha, on symptoms of schizophrenia and to investigate decreases in proinflammatory markers as a possible mechanism of action. METHODS: Schizophrenia subjects with a history of a recent exacerbation were randomly assigned to receive double-blind adjunctive treatment either with WSE or placebo for 12 weeks. Outcomes were assessed using the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression Scale (CGI), and the Perceived Stress Scale (PSS). Inflammatory markers were measured at baseline and 12 weeks. RESULTS: Among 47 randomized subjects, 24 received WSE and 23 received placebo. WSE treatment was not associated with a greater reduction in symptoms on the PANSS, the CGI, or the PSS. We did not find a significant effect of WSE on inflammatory markers and we did not find an association between changes in inflammatory measures and changes in symptoms. CONCLUSION: This clinical trial failed to find that WSE resulted in a statistically significant improvement of clinical measures or inflammatory markers. Disruptions from the COVID pandemic, the small sample size, heterogeneity, and baseline differences in psychopathology between the groups were important limitations of the study. However, the pattern that we observed did not indicate that the findings would have been different with a larger sample size or that the findings were influenced by the baseline differences.