Luteolin for the Treatment of People With Schizophrenia

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jan 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a natural substance called luteolin, which is found in foods like celery, green peppers, parsley, and chamomile tea. Researchers want to see if luteolin can help improve symptoms in people diagnosed with schizophrenia or schizoaffective disorder. The trial is currently recruiting participants aged 18 to 60 who are stable on their antipsychotic medication and meet specific criteria for their condition.

To be eligible, you must have a confirmed diagnosis of schizophrenia or schizoaffective disorder and have a certain score on a symptom assessment scale. Participants will need to provide informed consent, which means they understand the study and agree to take part. If you join the study, you will be monitored closely, and the researchers will evaluate how luteolin affects your symptoms. It's important to note that some individuals may not be able to participate, especially those with recent substance misuse or certain medical conditions.

Gender

ALL

Eligibility 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