Status:
COMPLETED
Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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...
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 thro...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00214877
Start Date
November 1 2003
End Date
October 1 2007
Last Update
April 1 2008
Active Locations (2)
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1
CDHA- QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H-2E2
2
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 3K7