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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Dietary supplement: Luteolin; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Zaranski; Phone Number: 410-402-6060; Email: jzaranski@som.umaryland.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Contact: Gerard DeVera; Phone Number: 310-794-5577; Email: gdevera@mednet.ucla.edu
      • Principal Investigator: Stephen R Marder, M.D.
  • Maryland
    • Baltimore, Maryland, United States, 21228
      • Recruiting
      • Maryland Psychiatric Research Center
      • Contact: Jennifer Zaranski; Phone Number: 410-402-6060; Email: jzaranski@som.umaryland.edu
      • Contact: Christine Brown; Phone Number: 410-402-7878; Email: cbrown@som.umaryland.edu
      • Principal Investigator: Robert W Buchanan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; The placebo target dose will be 300 mg BID taken over 12 weeks in capsule form
Active Comparator: Luteolin	Dietary supplement: Luteolin; The luteolin target dose will be 300 mg BID taken over 12 weeks in capsule form; Other Names: PureLut

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: University of California, Los Angeles; Stanley Medical Research Institute
• Investigators: Principal Investigator: Robert W Buchanan, M.D., University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: HP-00099288

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No