Clinical trial NCT05204407: Luteolin for the Treatment of People With Schizophrenia
Official title: Luteolin for the Treatment of People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Stanley Medical Research Institute
First posted: 2022-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled, parallel group, randomized clinical trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Global psychopathology
timeFrame: 12 weeks
measure: Cognitive impairments
timeFrame: 12 weeks
measure: Global oxidative stress
timeFrame: 12 weeks
measure: Cognition and oxidative stress
timeFrame: 12 weeks
Secondary outcomes:
measure: Positive symptoms of schizophrenia
timeFrame: 12 weeks
measure: Negative symptoms of schizophrenia
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Baltimore
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Robert W Buchanan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: