Effects of USP Methylene Blue on Cognitive and fMRI Brain Activity
Beneficial Effects of Methylene Blue on Human Cognitive and fMRI Measures
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of the study is to evaluate whether low-dose USP methylene blue (MB) will: i) improve short-term memory retention in a delayed match-to-sample task, ii) reduce reaction time in a psychomotor vigilance test, and iii) enhance responses to a visual-motor task as measured by functional magnetic resonance imaging (fMRI). A single low-dose MB or placebo will be orally administered to self-declared healthy adults using double-blind study design. Non-invasive fMRI data will be acquired before and after MB administration in the same subjects. Each study will take 2-3 hours, inclusive of an hour break in between.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Aug 2013
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 11, 2017
April 1, 2017
2.6 years
April 12, 2013
April 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement in reaction time assessed by fMRI measurements and PVT measurements
fMRI will be assessed using standard fMRI analysis tools. Psychomotor-Vigilance-Test (PVT) measurements will be made using a computer program written in Psychology Experiment Building Language (PBL).
1 hour
Improvement in memory assessed by fMRI measurements and DMS measurements
fMRI will be assessed using standard fMRI analysis tools. Delayed-match-to-sample task (DMS) measurements will be made using a computer program written in Psychology Experiment Building Language (PBL).
1 hour
Secondary Outcomes (1)
Enhanced fMRI responses to visual-motor task
1-2 hours
Study Arms (2)
Methylene Blue
EXPERIMENTALMethylene Blue, 280mg, oral, one time
Placebo
PLACEBO COMPARATORFD\&C Blue No. 2 (food dye), oral, one time
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 - 65 years, self declared healthy individuals
- English speaker and be able to give consent
You may not qualify if:
- Contraindication for MRI (pacemaker, metal implants, etc.)
- Claustrophobia
- Pregnant (child-bearing age females will be tested to exclude pregnancy onsite)
- Breast-feeding
- A history of hypersensitivity or allergy to methylene blue, glucose-6-phosphate dehydrogenase deficiency (determined via questionnaire)
- Neurological, mental, or cardiovascular disorders
- Liver, kidney disorders, kidney or liver transplant, hypertension, diabetes, etc.
- Known hypersensitivity to thiazide diuretics and phenothiazines
- A history of a psychotic disorder or panic disorder, violent or suicidal behavior, psychiatric institutionalization or imprisonment
- Methemoglobinemia
- On any psychiatric serotonergic antidepressant medication or drugs of abuse currently or within the last 5 weeks
- History of panic attack
- Color Blindness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Imaging Institute, The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Related Publications (6)
Riha PD, Bruchey AK, Echevarria DJ, Gonzalez-Lima F. Memory facilitation by methylene blue: dose-dependent effect on behavior and brain oxygen consumption. Eur J Pharmacol. 2005 Mar 28;511(2-3):151-8. doi: 10.1016/j.ejphar.2005.02.001.
PMID: 15792783BACKGROUNDGonzalez-Lima F, Bruchey AK. Extinction memory improvement by the metabolic enhancer methylene blue. Learn Mem. 2004 Sep-Oct;11(5):633-40. doi: 10.1101/lm.82404.
PMID: 15466319BACKGROUNDWrubel KM, Riha PD, Maldonado MA, McCollum D, Gonzalez-Lima F. The brain metabolic enhancer methylene blue improves discrimination learning in rats. Pharmacol Biochem Behav. 2007 Apr;86(4):712-7. doi: 10.1016/j.pbb.2007.02.018. Epub 2007 Mar 6.
PMID: 17428524BACKGROUNDWen Y, Li W, Poteet EC, Xie L, Tan C, Yan LJ, Ju X, Liu R, Qian H, Marvin MA, Goldberg MS, She H, Mao Z, Simpkins JW, Yang SH. Alternative mitochondrial electron transfer as a novel strategy for neuroprotection. J Biol Chem. 2011 May 6;286(18):16504-15. doi: 10.1074/jbc.M110.208447. Epub 2011 Mar 18.
PMID: 21454572BACKGROUNDLim J, Wu WC, Wang J, Detre JA, Dinges DF, Rao H. Imaging brain fatigue from sustained mental workload: an ASL perfusion study of the time-on-task effect. Neuroimage. 2010 Feb 15;49(4):3426-35. doi: 10.1016/j.neuroimage.2009.11.020. Epub 2009 Nov 24.
PMID: 19925871BACKGROUNDBruchey AK, Gonzalez-Lima F. Behavioral, Physiological and Biochemical Hormetic Responses to the Autoxidizable Dye Methylene Blue. Am J Pharmacol Toxicol. 2008 Jan 1;3(1):72-79. doi: 10.3844/ajptsp.2008.72.79.
PMID: 20463863BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Q. Duong, Ph.D.
The University of Texas Health Science Center at San Antonio
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2013
First Posted
April 19, 2013
Study Start
August 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 11, 2017
Record last verified: 2017-04