Luteolin for the Treatment of People With Schizophrenia

NCT ID: NCT05204407

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2026-01-14

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 purpose of this study is to determine if luteolin helps improve symptoms of schizophrenia.

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 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Luteolin

Group Type: ACTIVE_COMPARATOR

Luteolin

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Luteolin

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

PureLut

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Robert Buchanan

Chief, Maryland Psychiatric Research Center, Outpatient Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert W Buchanan, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of California, Los Angeles

Los Angeles, California, United States

Maryland Psychiatric Research Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00099288

Identifier Type: -

Identifier Source: org_study_id