Luteolin for the Treatment of People With Schizophrenia

Last updated: May 14, 2025
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tourette's Syndrome

Mood Disorders

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

Placebo

Luteolin

Clinical Study ID

NCT05204407
HP-00099288
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ClinicalGlobal 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 aconstant therapeutic dose for at least 30 days prior to study entry

  • Able to participate in the informed consent process and provide voluntary informedconsent

Exclusion

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 whomeet 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 ormedical condition, whose pathology or treatment could alter the presentation ortreatment of schizophrenia or significantly increase the risk associated with theproposed treatment protocol

  • Currently taking immunosuppressive medications (e.g. oral scheduled corticosteroids,chemotherapy or transplantation or HIV/AIDs associated drugs); or anti-inflammatorymedications, 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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
June 13, 2022
Estimated Completion Date:
September 30, 2025

Study 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 residual symptoms and cognitive impairments. The study will be conducted at two sites: The Maryland Psychiatric Research Center (MPRC) and the University of California Los Angeles (UCLA). Participants will be randomized to either 300mg BID luteolin (three 100mg capsules) or placebo. We hypothesize that luteolin will have significant beneficial effects on global psychopathology and cognitive impairments; decrease antioxidant stress and levels of inflammatory markers; and that improvement in global psychopathology and cognition will be associated with changes in the oxidative stress and inflammatory measures. We also hypothesize that luteolin will be associated with improvements in positive and negative symptoms of schizophrenia.

Connect with a study center

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Maryland Psychiatric Research Center

    Baltimore, Maryland 21228
    United States

    Active - Recruiting

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