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Luteolin for the Treatment of People With Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Luteolin
Placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Los AngelesRecruiting
  • Maryland Psychiatric Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Luteolin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Global psychopathology
To determine if luteolin is superior to placebo for the treatment of global psychopathology.
Cognitive impairments
To determine if luteolin is superior to placebo for the treatment of cognitive impairments.
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.
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

Secondary Outcome Measures

Positive symptoms of schizophrenia
To determine if luteolin is superior to placebo for positive symptoms.
Negative symptoms of schizophrenia
To determine if luteolin is superior to placebo for negative symptoms.

Full Information

First Posted
January 11, 2022
Last Updated
June 26, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
University of California, Los Angeles, Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05204407
Brief Title
Luteolin for the Treatment of People With Schizophrenia
Official Title
Luteolin for the Treatment of People With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
University of California, Los Angeles, Stanley Medical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, placebo-controlled, parallel group, randomized clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Luteolin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Luteolin
Other Intervention Name(s)
PureLut
Intervention Description
The luteolin target dose will be 300 mg BID taken over 12 weeks in capsule form
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo target dose will be 300 mg BID taken over 12 weeks in capsule form
Primary Outcome Measure Information:
Title
Global psychopathology
Description
To determine if luteolin is superior to placebo for the treatment of global psychopathology.
Time Frame
12 weeks
Title
Cognitive impairments
Description
To determine if luteolin is superior to placebo for the treatment of cognitive impairments.
Time Frame
12 weeks
Title
Global oxidative stress
Description
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.
Time Frame
12 weeks
Title
Cognition and oxidative stress
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Positive symptoms of schizophrenia
Description
To determine if luteolin is superior to placebo for positive symptoms.
Time Frame
12 weeks
Title
Negative symptoms of schizophrenia
Description
To determine if luteolin is superior to placebo for negative symptoms.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Zaranski
Phone
410-402-6060
Email
jzaranski@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Buchanan, M.D.
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard DeVera
Phone
310-794-5577
Email
gdevera@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Stephen R Marder, M.D.
Facility Name
Maryland Psychiatric Research Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Brown
Phone
410-402-7878
Email
cbrown@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Zaranski
Phone
410-402-6060
Email
jzaranski@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Robert W Buchanan, MD

12. IPD Sharing Statement

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Luteolin for the Treatment of People With Schizophrenia

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