Effects of USP Methylene Blue on Cognitive and fMRI Brain Activity
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Brain Activity
In brief
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.
Key facts
- Study ID
- NCT01836094
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 36
- Starts
- 2013-08-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2017-04-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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
- Any other condition, which in the opinion of the investigator, would put the participant at risk and warrant exclusion from the study
- Methemoglobinemia
- On any psychiatric serotonergic antidepressant medication or drugs of abuse currently or within the last 5 weeks
- History of panic attack
- Color Blindness
Where it is running
- Research Imaging Institute, The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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