Depression, Obesity and Inflammatory Markers
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|ClinicalTrials.gov Identifier: NCT02765100|
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : November 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depression Obesity||Drug: Minocycline||Not Applicable|
Aim 1 will examine relationships between the levels of the inflammatory markers and current clinical state (depressed, manic or euthymic) with the hypothesis that Inflammatory markers will be higher in depression and mania relative to the euthymic state.
Aim 2 will examine relationships between inflammatory markers and BMI in bipolar patients with the hypothesis that inflammatory markers will correlate positively with BMI.
Aim 3 will examine the relationship between depression, obesity and inflammatory markers with the hypothesis that depressed (or manic) bipolar patients who are also obese will have higher inflammatory markers than either obese euthymic patients or non-obese depressed or manic patients.
Aim 4. The pilot study will be to conduct a proof of concept add-on treatment study of the antibiotic minocycline for bipolar patients who are depressed, likely to be obese and likely to have elevated inflammatory markers and increased risk of heart disease. This is a proposal to conduct a 2-site trial of 50 subjects to examine the value of minocycline augmentation in bipolar depressed patients who are incompletely responsive to initial treatment with anti depressants and/or mood stabilizers. The investigators will compare two subgroups of depressed patients, those who have high (N=25) versus those who have low (N=25) levels of C-reactive protein (CRP) as defined below.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Depression, Obesity and Inflammatory Markers|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 2019|
|Actual Study Completion Date :||October 2019|
Experimental: Pilot Study
This will be to conduct a proof of concept add-on treatment study of the antibiotic minocycline for bipolar patients who are depressed at the time of screen. This will examine the value of minocycline augmentation in bipolar depressed patients who are incompletely responsive to initial treatment with anti depressants and/or mood stabilizers. This will be completely open trial and offered to any participant who is depressed at screen.
In various models of neurodegenerative disease, minocycline has demonstrated neurorestorative as well as neuroprotective properties.
Other Name: Minocin
- C-reactive protein (CRP) [ Time Frame: One Day ]Low = CRP level of less than 1.0 milligram per liter (mg/L). Average = CRP level between 1.0 and 3.0 mg/L. High= CRP level greater than 3.0 mg/L.
- Hamilton Depression Scale change score [ Time Frame: 6 weeks ]Scale ranges from 0-65, greater change is better
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765100
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||James H Kocsis, MD||Weill CMC|