Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214877
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2005-09-20
Brief Title:
Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
Double-Blind Trial of Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Stanley Foundation 02T-166 | None | None | None |