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Luteolin for the Treatment of People With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05204407
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : July 27, 2022
Sponsor:
Collaborators:
University of California, Los Angeles
Stanley Medical Research Institute
Information provided by (Responsible Party):
Robert Buchanan, University of Maryland, Baltimore

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Dietary Supplement: Luteolin Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, parallel group, randomized clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Luteolin for the Treatment of People With Schizophrenia
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Luteolin Dietary Supplement: Luteolin
The luteolin target dose will be 300 mg BID taken over 12 weeks in capsule form
Other Name: PureLut
Placebo Comparator: Placebo Dietary Supplement: Placebo
The placebo target dose will be 300 mg BID taken over 12 weeks in capsule form


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05204407


Contacts
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Contact: Jennifer Zaranski 410-402-6060 jzaranski@som.umaryland.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Gerard DeVera    310-794-5577    gdevera@mednet.ucla.edu   
Principal Investigator: Stephen R Marder, M.D.         
United States, Maryland
Maryland Psychiatric Research Center Recruiting
Baltimore, Maryland, United States, 21228
Contact: Christine Brown    410-402-7878    cbrown@som.umaryland.edu   
Contact: Jennifer Zaranski    410-402-6060    jzaranski@som.umaryland.edu   
Principal Investigator: Robert W Buchanan, MD         
Sponsors and Collaborators
University of Maryland, Baltimore
University of California, Los Angeles
Stanley Medical Research Institute
Investigators
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Principal Investigator: Robert W Buchanan, M.D. University of Maryland, Baltimore
More Information
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Responsible Party: Robert Buchanan, Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT05204407    
Other Study ID Numbers: HP-00099288
First Posted: January 24, 2022    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders