Luteolin for the Treatment of People With Schizophrenia

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2025

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.

Interventions

  • Dietary Supplement: Luteolin
    • The luteolin target dose will be 300 mg BID taken over 12 weeks in capsule form
  • Dietary Supplement: Placebo
    • The placebo target dose will be 300 mg BID taken over 12 weeks in capsule form

Arms, Groups and Cohorts

  • Active Comparator: Luteolin
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Global psychopathology
    • Time Frame: 12 weeks
    • To determine if luteolin is superior to placebo for the treatment of global psychopathology.
  • Cognitive impairments
    • Time Frame: 12 weeks
    • To determine if luteolin is superior to placebo for the treatment of cognitive impairments.
  • 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.
  • 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 Measures

  • Positive symptoms of schizophrenia
    • Time Frame: 12 weeks
    • To determine if luteolin is superior to placebo for positive symptoms.
  • Negative symptoms of schizophrenia
    • Time Frame: 12 weeks
    • To determine if luteolin is superior to placebo for negative symptoms.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Maryland, Baltimore
  • Collaborator
    • University of California, Los Angeles
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert Buchanan, Chief, Maryland Psychiatric Research Center, Outpatient Research Program – University of Maryland, Baltimore
  • Overall Official(s)
    • Robert W Buchanan, M.D., Principal Investigator, University of Maryland, Baltimore
  • Overall Contact(s)
    • Jennifer Zaranski, 410-402-6060, jzaranski@som.umaryland.edu

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