Luteolin for the Treatment of People With Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05204407|
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : July 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Dietary Supplement: Luteolin Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, placebo-controlled, parallel group, randomized clinical trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Luteolin for the Treatment of People With Schizophrenia|
|Actual Study Start Date :||June 13, 2022|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2025|
|Active Comparator: Luteolin||
Dietary Supplement: Luteolin
The luteolin target dose will be 300 mg BID taken over 12 weeks in capsule form
Other Name: PureLut
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
The placebo target dose will be 300 mg BID taken over 12 weeks in capsule form
- Global psychopathology [ Time Frame: 12 weeks ]To determine if luteolin is superior to placebo for the treatment of global psychopathology.
- Cognitive impairments [ Time Frame: 12 weeks ]To determine if luteolin is superior to placebo for the treatment of cognitive impairments.
- Global oxidative stress [ Time Frame: 12 weeks ]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 [ Time Frame: 12 weeks ]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
- Positive symptoms of schizophrenia [ Time Frame: 12 weeks ]To determine if luteolin is superior to placebo for positive symptoms.
- Negative symptoms of schizophrenia [ Time Frame: 12 weeks ]To determine if luteolin is superior to placebo for negative symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05204407
|Contact: Jennifer Zaranskiemail@example.com|
|United States, California|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Gerard DeVera 310-794-5577 firstname.lastname@example.org|
|Principal Investigator: Stephen R Marder, M.D.|
|United States, Maryland|
|Maryland Psychiatric Research Center||Recruiting|
|Baltimore, Maryland, United States, 21228|
|Contact: Christine Brown 410-402-7878 email@example.com|
|Contact: Jennifer Zaranski 410-402-6060 firstname.lastname@example.org|
|Principal Investigator: Robert W Buchanan, MD|
|Principal Investigator:||Robert W Buchanan, M.D.||University of Maryland, Baltimore|