Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

What Was Tested

In this phase 3 trial, researchers set out to test Methylene blue (non-peptide stack partner).

Methylene blue is an available 'over the counter medication' in Canada.

The registry classes the interventions as drug.

More on the Plan

This is a double blind cross-over study.

This design is necessary because methylene blue stains urine and thus it is not possible to use a traditional placebo.

Double-blind means that neither the doctor nor the patient will know which strength of study drug the patient will be on at what point in the study.

The study will be conducted in three centres, each recruiting 20 subjects over a two-year period.

Who Took Part

40 planned participants were the target.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men or women between the ages of 18 and 65 who meet both RDC and DSM-IV criteria for bipolar I or bipolar II disorder will be recruited. All subjects will be interviewed using SADS interview (40) with added questions as to arrive at DSM-IV diagnoses as well. HAM-D (17 item) scores at study entry will be 15 or lower and Y MRS scores will be less than 15.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: patients not able to give informed consent; patients with active substance abuse or dependence or a history of such within the past two years; physical illness, mainly liver and kidney disorders and g-6-pd deficiency.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Methylene blue (non-peptide stack partner) and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

It started in 2003-11 with completion listed for 2007-10.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Young Mania Rating Scale. Hamilton Depression Rating Scale (HAM-D), 17-item version Hamilton Rating Scale for Anxiety (HAM-A). Clinical Global Impression Scale CGI-BP (41).

It also tracked 3 secondary outcomes, for example Trails B will be administered as a test of executive function.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 40 people.

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.