Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder	Drug: Methylene Blue	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Double-Blind Trial of Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
Study Start Date :	November 2003
Actual Study Completion Date :	October 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Young Mania Rating Scale
2. Hamilton Depression Rating Scale (HAM-D), 17-item version Hamilton Rating Scale for Anxiety (HAM-A).
3. Clinical Global Impression Scale CGI-BP (41)
4. Affective Morbidity Index (42)

Secondary Outcome Measures :

1. California Verbal Learning Task and a process dissociation task. Two tasks will focus on selective attention, negative priming and inhibition of return tasks.
2. A visual backward masking task that has been well studied in patients with BD will be used.
3. Trails B will be administered as a test of executive function.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

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Locations

Canada, Nova Scotia
CDHA- QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H-2E2
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 3K7

Sponsors and Collaborators

Nova Scotia Health Authority

Stanley Medical Research Institute

Investigators

Principal Investigator:	Martin Alda, MD FRCPC	Dalhousie University

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Alda M, McKinnon M, Blagdon R, Garnham J, MacLellan S, O'Donovan C, Hajek T, Nair C, Dursun S, MacQueen G. Methylene blue treatment for residual symptoms of bipolar disorder: randomised crossover study. Br J Psychiatry. 2017 Jan;210(1):54-60. doi: 10.1192/bjp.bp.115.173930. Epub 2016 Jun 9.

ClinicalTrials.gov Identifier:	NCT00214877 History of Changes
Other Study ID Numbers:	QE-RS/2002-173; Stanley Foundation # 02T-166
First Posted:	September 22, 2005
Last Update Posted:	April 1, 2008
Last Verified:	March 2008

Keywords provided by Nova Scotia Health Authority:

methylene blue for cognitive dysfunction in bipolar disorder

Additional relevant MeSH terms:

Disease; Bipolar Disorder; Cognitive Dysfunction; Pathologic Processes; Bipolar and Related Disorders; Mental Disorders	Cognition Disorders; Neurocognitive Disorders; Methylene Blue; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action