Overview

Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nova Scotia Health Authority
Collaborator:
Stanley Medical Research Institute
Treatments:
Methylene Blue
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)