Status:
RECRUITING
Luteolin for the Treatment of People With Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
University of California, Los Angeles
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 purpos...
Detailed Description
The study is a 12-week, double-blind, placebo-controlled, parallel group, randomized clinical trial of the efficacy of luteolin for the treatment of people with schizophrenia, who present with residua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05204407
Start Date
June 13 2022
End Date
December 1 2025
Last Update
October 17 2025
Active Locations (2)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228