Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Stephen R Marder, M.D.

Description

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.

Details

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.

Keywords

Schizophrenia, Schizoaffective Disorder, Psychotic Disorders, Luteolin

Eligibility

You can join if…

Open to people ages 18-60

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Maryland Psychiatric Research Center accepting new patients
    Baltimore Maryland 21228 United States

Lead Scientist at UCLA

  • Stephen R Marder, M.D.
    Dr. Stephen Marder holds the Dr. Daniel X. Freedman Administrative Chair in Academic Psychiatry.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Maryland, Baltimore
ID
NCT05204407
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated