NCT05204407

Luteolin for the Treatment of People With Schizophrenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-13
• Primary completion: 2026-01-14
• Completion: 2026-01-14
• First posted: 2022-01-24
• Last updated: 2026-01-23

Locations

2 sites across 1 country: United States