Back to resultsMethylene Blue for Cognitive Dysfunction in Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Methylene Blue
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring methylene blue for cognitive dysfunction in bipolar disorder
Eligibility 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)
Sites / Locations
- CDHA- QE II Health Sciences Centre
- St. Joseph's Healthcare
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00214877
First Posted
September 20, 2005
Last Updated
March 28, 2008
Sponsor
Nova Scotia Health Authority
Collaborators
Stanley Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00214877
Brief Title
Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
Official Title
Double-Blind Trial of Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Stanley Medical Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
methylene blue for cognitive dysfunction in bipolar disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Primary Outcome Measure Information:
Title
Young Mania Rating Scale
Title
Hamilton Depression Rating Scale (HAM-D), 17-item version Hamilton Rating Scale for Anxiety (HAM-A).
Title
Clinical Global Impression Scale CGI-BP (41)
Title
Affective Morbidity Index (42)
Secondary Outcome Measure Information:
Title
California Verbal Learning Task and a process dissociation task. Two tasks will focus on selective attention, negative priming and inhibition of return tasks.
Title
A visual backward masking task that has been well studied in patients with BD will be used.
Title
Trails B will be administered as a test of executive function.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Alda, MD FRCPC
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDHA- QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H-2E2
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27284082
Citation
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.
Results Reference
derived
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Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
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