Effects of USP Methylene Blue on Cognitive and fMRI Brain Activity

What Was Tested

This registered early phase 1 trial tested Methylene blue (non-peptide stack partner).

Non-invasive fMRI data will be acquired before and after MB administration in the same subjects.

It had two arms (groups): Methylene Blue (experimental) and Placebo (placebo comparator).

FD\&C Blue No. 2 (food dye), oral, one time.

The registry classes the interventions as drug.

More on the Plan

After informed consent and familiarity with the tasks and the MRI environment, the subject will enter an MRI scanner and perform the following 3 tasks: Delayed match-to-sample task: The subject views an object for a few seconds.

After a few (variable) seconds, the subject is presented with two patterns and the subject needs to press the left or right button based on whether the picture on the left or the right is the same as the previous picture.

The correct and incorrect answers are recorded.

A few of these trials will be cycled, lasting about 5-10 mins.

Who Took Part

The registry lists 36 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: English speaker and be able to give consent.

The full record lists 2 inclusion and 14 exclusion criteria; among the exclusions: contraindication for mri (pacemaker, metal implants, etc.); pregnant (child-bearing age females will be tested to exclude pregnancy onsite); A history of hypersensitivity or allergy to methylene blue, glucose-6-phosphate dehydrogenase deficiency (determined via questionnaire).

How the Study Was Run

Design: randomized, single-group and double-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2013-08 with completion listed for 2016-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 1 secondary outcome, for example Enhanced fMRI responses to visual-motor task.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Methylene blue (non-peptide stack partner) in 36 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.