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Last Updated: July 2, 2020

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CLINICAL TRIALS PROFILE FOR METHYLENE BLUE

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505(b)(2) Clinical Trials for Methylene Blue

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00214877 Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Stanley Medical Research Institute Phase 3 2003-11-01 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.
OTC NCT00214877 Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Nova Scotia Health Authority Phase 3 2003-11-01 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Methylene Blue

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00070317 Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer Terminated National Cancer Institute (NCI) N/A 2004-06-01 This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
NCT00070317 Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer Terminated Gynecologic Oncology Group N/A 2004-06-01 This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
NCT00131599 Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to 5-Fluorouracil Based Chemotherapy in Stage III Colon Cancer Unknown status AHS Cancer Control Alberta N/A 2002-08-01 Cancer of the colon and rectum are the third most common cancers in Canadian males and females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby lymph glands. If the cancer has spread to the lymph glands there is a high chance that the cancer will come back. To reduce the risk of the cancer recurring, patients are treated with an anticancer drug 5-fluorouracil (5FU) in combination with a vitamin leucovorin (LV). This study will determine if a simple blood test can predict which patients are at risk for developing side effects from this chemotherapy. In addition, participants of this study will be followed to determine if this same blood test will predict which patients will have their cancer relapse.
NCT00159510 Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome Terminated Helse Nord Phase 1 2004-04-01 Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in sepsis the excessive production of NO results in myocardial depression, vasoplegia, and cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed study from our group showed advantageous cardiovascular effects of continuously infused methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another investigation, we have found that the combination of inhaled NO and continuously infused MB attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both cardiovascular and pulmonary functions as well as clinical outcome in patients with septic shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic shock and ALI, will be randomized to groups receiving 1. Conventional treatment (control group)(n =10); 2. MB infusion in addition to conventional treatment (n=10); 3. Inhaled NO in addition to conventional treatment (n=10); 4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment (n=10).
NCT00159510 Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome Terminated Northern State Medical University Phase 1 2004-04-01 Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in sepsis the excessive production of NO results in myocardial depression, vasoplegia, and cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed study from our group showed advantageous cardiovascular effects of continuously infused methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another investigation, we have found that the combination of inhaled NO and continuously infused MB attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both cardiovascular and pulmonary functions as well as clinical outcome in patients with septic shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic shock and ALI, will be randomized to groups receiving 1. Conventional treatment (control group)(n =10); 2. MB infusion in addition to conventional treatment (n=10); 3. Inhaled NO in addition to conventional treatment (n=10); 4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment (n=10).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Methylene Blue

Condition Name

Condition Name for Methylene Blue
Intervention Trials
Septic Shock 4
Malaria 4
Breast Cancer 3
Sepsis 3
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Condition MeSH

Condition MeSH for Methylene Blue
Intervention Trials
Malaria 6
Shock, Septic 5
Shock 5
Prostatic Neoplasms 5
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Clinical Trial Locations for Methylene Blue

Trials by Country

Trials by Country for Methylene Blue
Location Trials
United States 101
China 24
Canada 9
Brazil 6
Burkina Faso 5
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Trials by US State

Trials by US State for Methylene Blue
Location Trials
Pennsylvania 7
New York 6
Maryland 6
Texas 6
Massachusetts 5
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Clinical Trial Progress for Methylene Blue

Clinical Trial Phase

Clinical Trial Phase for Methylene Blue
Clinical Trial Phase Trials
Phase 4 7
Phase 3 9
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Methylene Blue
Clinical Trial Phase Trials
Completed 30
Not yet recruiting 19
Recruiting 18
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Clinical Trial Sponsors for Methylene Blue

Sponsor Name

Sponsor Name for Methylene Blue
Sponsor Trials
National Cancer Institute (NCI) 7
Heidelberg University 7
Isofol Medical AB 3
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Sponsor Type

Sponsor Type for Methylene Blue
Sponsor Trials
Other 119
Industry 17
NIH 9
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