Luteolin for the Treatment of People With Schizophrenia (NCT05204407) | Clinical Trial Compass
CompletedNot Applicable
Luteolin for the Treatment of People With Schizophrenia
United States85 participantsStarted 2022-06-13
Plain-language summary
Luteolin is a natural product found in foods such as celery, green pepper, parsley, and chamomile tea. It has been found to have anti-cancer, anti-oxidant, and anti-inflammatory properties. The purpose of this study is to determine if luteolin helps improve symptoms of schizophrenia.
Who can participate
Age range18 Years – 60 Years
SexALL
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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