Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine.
Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Double-Blind Trial of Methylene Blue for Cognitive Dysfunction in Bipolar Disorder|
- 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)
- Affective Morbidity Index (42)
- California Verbal Learning Task and a process dissociation task. Two tasks will focus on selective attention, negative priming and inhibition of return tasks.
- A visual backward masking task that has been well studied in patients with BD will be used.
- Trails B will be administered as a test of executive function.
|Study Start Date:||November 2003|
|Study Completion Date:||October 2007|
This is a double blind cross-over study. There are two dose ranges in this study. A cross over design means that some patients will start at one dose range and others with another. About half way through the study, patients will then be switched over to the other dose range. Patients partially stabilized on lamotrigine will be randomized to either subtherapeutic (16mg) or therapeutic (200mg) dose of methylene blue. 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. The duration of the study is 6 months.
|Canada, Nova Scotia|
|CDHA- QE II Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H-2E2|
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 3K7|
|Principal Investigator:||Martin Alda, MD FRCPC||Dalhousie University|