Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
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ClinicalTrials.gov Identifier: NCT00214877 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: April 1, 2008
|
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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 |
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 |

- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214877
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 |
Principal Investigator: | Martin Alda, MD FRCPC | Dalhousie University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00214877 History of Changes |
Other Study ID Numbers: |
QE-RS/2002-173 Stanley Foundation # 02T-166 |
First Posted: | September 22, 2005 Key Record Dates |
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 |