Using luteolin to treat schizophrenia symptoms
Luteolin for the Treatment of People With Schizophrenia
This study is testing if taking a natural compound called luteolin can help improve symptoms for people with schizophrenia and schizoaffective disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05204407 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of luteolin, a natural compound found in various foods, in improving symptoms of schizophrenia and schizoaffective disorder. It is a 12-week, double-blind, placebo-controlled study involving participants who have residual symptoms and cognitive impairments. Participants will be randomly assigned to receive either 300mg of luteolin twice daily or a placebo, with the aim of assessing changes in global psychopathology, cognitive function, oxidative stress, and inflammatory markers. The study is conducted at two prominent research sites: the Maryland Psychiatric Research Center and UCLA.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of schizophrenia or schizoaffective disorder who are clinically stable and on a consistent antipsychotic regimen.
Not a fit: Patients with current substance misuse issues or significant medical conditions that could interfere with the study outcomes may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for improving symptoms and cognitive impairments in patients with schizophrenia.
How similar studies have performed: While the use of luteolin in this context is novel, previous studies have shown promise for natural compounds in treating psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Either male or female of any race * Age is 18-60 years old * Meets DSM-5 criteria for schizophrenia or schizoaffective disorder * Positive and Negative Syndrome Scale (PANSS) total score of 75 or more OR a Clinical Global Impression severity of illness item score of 4 or more * Clinically stable * Treated with the same antipsychotic for at least 60 days and have received a constant therapeutic dose for at least 30 days prior to study entry * Able to participate in the informed consent process and provide voluntary informed consent Exclusion Criteria: * Meets DSM-5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 6 months; or a positive baseline urine drug screen. Participants who meet DSM-5 criteria for marijuana misuse - mild will be included in the study * A current infection, including HIV and Hepatitis C; or an organic brain disorder or medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol * Currently taking immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs); or anti-inflammatory medications, including NSAIDs (e.g. ibuprofen, celecoxib, or naproxen) or aspirin \> 81 mg on a daily basis. The use of PRN anti-inflammatory agents will be allowed. * Female participants who are pregnant or nursing
Where this trial is running
Los Angeles, California and 1 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
- Maryland Psychiatric Research Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Robert W Buchanan, M.D. — University of Maryland, Baltimore
- Study coordinator: Jennifer Zaranski
- Email: jzaranski@som.umaryland.edu
- Phone: 410-402-6060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.