Luteolin for the Treatment of People With Schizophrenia

NCT05204407 | Completed DMC

• 1 other identifier: HP-00099288
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (4)

• Global psychopathology

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

  12 weeks

• Cognitive impairments

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

  12 weeks

• Global oxidative stress

  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.

  12 weeks

• Cognition and oxidative stress

  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

  12 weeks

Secondary Outcomes (2)

• Positive symptoms of schizophrenia

  12 weeks

• Negative symptoms of schizophrenia

  12 weeks

Study Arms (2)

Luteolin

ACTIVE COMPARATOR

Dietary Supplement: Luteolin

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Luteolin DIETARY_SUPPLEMENT

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

Also known as: PureLut

Luteolin

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of California, Los Angeles: collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Maryland Psychiatric Research Center

Baltimore, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Luteolin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Deanna Kelly, PharmD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Maryland Psychiatric Research Center

Model Details: Double-blind, placebo-controlled, parallel group, randomized clinical trial.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 24, 2022
• Study Start: June 13, 2022
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (2)