Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Double-Blind Trial of Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214877
• Other study ID #: QE-RS/2002-173
• Secondary ID: Stanley Foundati
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2005
• Last updated: March 28, 2008
• Start date: November 2003
• Est. completion date: October 2007

Study information

• Verified date: March 2008
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

• The patients will be treated with lamotrigine as their main mood stabilizer. Patients recruited for the study will show at least partial response to prophylactic treatment with respect to the mood symptoms.

• HAM-D (17 item) scores at study entry will be 15 or lower and Y MRS scores will be less than 15.

Exclusion Criteria:

• 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

• Subjects previously treated with methylene blue

• Pregnant or breast-feeding women

• Subjects who have had ECT within the past two years

• Patients with known brain injury or loss of consciousness of duration greater than ten minutes

• Subjects taking concurrent medications that are known to have cognitive effects (eg. beta blockers)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognition Disorders

Intervention

Drug:
• Methylene Blue

Locations

Country	Name	City	State
Canada	CDHA- QE II Health Sciences Centre	Halifax	Nova Scotia
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Stanley Medical Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Young Mania Rating Scale
Primary	Hamilton Depression Rating Scale (HAM-D), 17-item version Hamilton Rating Scale for Anxiety (HAM-A).
Primary	Clinical Global Impression Scale CGI-BP (41)
Primary	Affective Morbidity Index (42)
Secondary	California Verbal Learning Task and a process dissociation task. Two tasks will focus on selective attention, negative priming and inhibition of return tasks.
Secondary	A visual backward masking task that has been well studied in patients with BD will be used.
Secondary	Trails B will be administered as a test of executive function.