NCT02765100

Depression, Obesity and Inflammatory Markers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to better understand the relationship between bipolar disorder, body weight, and inflammation in the body (N=180). People with bipolar depression (N = 50)will be offered a place in a pilot study looking to see if the antibiotic minocycline added to current psychiatric medications has an effect on mood. A separate consent form will be provided for the pilot study. Numerous studies have documented the presence of altered immune function and elevation of inflammatory markers in patients with depression. Studies suggest that major depression is accompanied by immune dysregulation and activation of the inflammatory response system. While a small number of studies have found elevated inflammatory markers in bipolar mania, very little has been reported about inflammation in bipolar depression, and none of these studies have addressed the relationship of inflammatory markers with obesity in bipolar disorder.

Detailed description

Aim 1 (N=180)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 (N=180)will examine relationships between inflammatory markers and BMI in bipolar patients with the hypothesis that inflammatory markers will correlate positively with BMI. Aim 3 (N=180)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. (N=50) 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).

Conditions

• Bipolar Disorder
• Depression
• Obesity

Interventions

Type	Name	Description
DRUG	Minocycline	Minocycline 100 mg twice a day

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-05-06
• Last updated: 2020-07-01
• Results posted: 2020-07-01

Locations

1 site across 1 country: United States