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Completed

NCT Number: NCT05204407

Luteolin for the Treatment of People With Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Luteolin

Dietary Supplement

The luteolin target dose will be 300 mg BID taken over 12 weeks in capsule form

Other names: PureLut

Placebo

Dietary Supplement

The placebo target dose will be 300 mg BID taken over 12 weeks in capsule form

Primary outcomes

  1. Global psychopathology

    Time frame: 12 weeks

    To determine if luteolin is superior to placebo for the treatment of global psychopathology.

  2. Cognitive impairments

    Time frame: 12 weeks

    To determine if luteolin is superior to placebo for the treatment of cognitive impairments.

  3. Global oxidative stress

    Time frame: 12 weeks

    To determine if luteolin compared to placebo is associated with a decrease in the global measure of oxidative stress and/or a reduction in the levels of the inflammatory markers.

  4. Cognition and oxidative stress

    Time frame: 12 weeks

    To determine if changes in symptom or cognitive measures are associated with changes in the global measure of oxidative stress and/or the levels of inflammatory markers

Secondary outcomes

  1. Positive symptoms of schizophrenia

    Time frame: 12 weeks

    To determine if luteolin is superior to placebo for positive symptoms.

  2. Negative symptoms of schizophrenia

    Time frame: 12 weeks

    To determine if luteolin is superior to placebo for negative symptoms.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Stanley Medical Research Institute
  • University of California, Los Angeles

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2022
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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