Luteolin for the Treatment of People With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Luteolin for the Treatment of People With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204407
• Other study ID #: HP-00099288
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: March 2025

Study information

• Verified date: June 2023
• Source: University of Maryland, Baltimore
• Contact: Jennifer Zaranski
• Phone: 410-402-6060
• Email: jzaranski[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center	Baltimore	Maryland
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Stanley Medical Research Institute, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global psychopathology	To determine if luteolin is superior to placebo for the treatment of global psychopathology.	12 weeks
Primary	Cognitive impairments	To determine if luteolin is superior to placebo for the treatment of cognitive impairments.	12 weeks
Primary	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
Primary	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	Positive symptoms of schizophrenia	To determine if luteolin is superior to placebo for positive symptoms.	12 weeks
Secondary	Negative symptoms of schizophrenia	To determine if luteolin is superior to placebo for negative symptoms.	12 weeks