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Depression, Obesity and Inflammatory Markers

Primary Purpose

Bipolar Disorder, Depression, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Minocycline

About this trial

This is an interventional other trial for Bipolar Disorder focused on measuring Bipolar Disorder, Obesity, Depression

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with Bipolar Disorder and current depressive symptoms
Hamilton Depression Scale score > 18
Failed an adequate trial of at least one antidepressant or mood stabilizer of at least 4 weeks duration. Medication history will be recorded using the Antidepressant Treatment History Form
18 years or older
Fluent in English or Arabic
Have the capacity to understand the nature of the study and sign the written informed consent.

Exclusion Criteria:

A current diagnosis of Schizophrenia or other psychotic disorder, or Dementia Alzheimer Type or related cognitive disorders.
Principal diagnosis of Post-Traumatic Stress Disorder, Anorexia or Bulimia Nervosa, Obsessive-Compulsive Disorder. We define principal as the most pressing clinical problem.
Pregnant or nursing
Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder (defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
Patients who currently meet criteria for Alcohol or other Substance-Related Dependence Disorder (with the exception of nicotine dependence) who require detoxification.
Patients who are unable to read and write English or Arabic.
Patients having serious, unstable or terminal medical or neurologic illness that would compromise study participation (i.e., metastatic or advanced malignancy, chronic renal failure requiring dialysis, recent myocardial infarction or unstable angina, or "end stage" chronic obstructive pulmonary disease). People with common conditions such as hypertension, insulin dependent diabetes mellitus, asthma, compensated congestive heart failure, a malignancy in remission, treated hypothyroidism, or epilepsy will not be excluded from participation.
Autoimmune disease or chronic inflammatory diseases such as psoriasis or Crohn's disease
Chronic infection such as hepatitis B or C or HIV
Elevated antinuclear antibody or rheumatoid factor
Oral glucocorticoids in the past 6 months
Methotrexate or NSAID use in the past two weeks

Sites / Locations

Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Low CRP

High CRP

Arm Description

Subjects have CRP > 3

Subjects have CRP =/> 3

Outcomes

Primary Outcome Measures

Change in Depression as Measured by the Hamilton Depression Scale Collected at Baseline and Week 8

Scale ranges from 0-52. Greater change means greater improvement of depression from baseline to week 8.

Secondary Outcome Measures

Full Information

NCT ID

NCT02765100

First Posted

May 3, 2016

Last Updated

June 16, 2020

Sponsor

Weill Medical College of Cornell University

Collaborators

Weill Cornell Medical College in Qatar

1. Study Identification

Unique Protocol Identification Number

NCT02765100

Brief Title

Depression, Obesity and Inflammatory Markers

Official Title

Depression, Obesity and Inflammatory Markers

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

October 2014 (Actual)

Primary Completion Date

October 2019 (Actual)

Study Completion Date

October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Weill Cornell Medical College in Qatar

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Depression, Obesity

Keywords

Bipolar Disorder, Obesity, Depression

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low CRP

Arm Type

Experimental

Arm Description

Subjects have CRP > 3

Arm Title

High CRP

Arm Type

Experimental

Arm Description

Subjects have CRP =/> 3

Intervention Type

Drug

Intervention Name(s)

Minocycline

Other Intervention Name(s)

Minocin

Intervention Description

Minocycline 100 mg twice a day

Primary Outcome Measure Information:

Title

Change in Depression as Measured by the Hamilton Depression Scale Collected at Baseline and Week 8

Description

Scale ranges from 0-52. Greater change means greater improvement of depression from baseline to week 8.

Time Frame

Baseline; week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with Bipolar Disorder and current depressive symptoms Hamilton Depression Scale score > 18 Failed an adequate trial of at least one antidepressant or mood stabilizer of at least 4 weeks duration. Medication history will be recorded using the Antidepressant Treatment History Form 18 years or older Fluent in English or Arabic Have the capacity to understand the nature of the study and sign the written informed consent. Exclusion Criteria: A current diagnosis of Schizophrenia or other psychotic disorder, or Dementia Alzheimer Type or related cognitive disorders. Principal diagnosis of Post-Traumatic Stress Disorder, Anorexia or Bulimia Nervosa, Obsessive-Compulsive Disorder. We define principal as the most pressing clinical problem. Pregnant or nursing Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder (defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior). Patients who currently meet criteria for Alcohol or other Substance-Related Dependence Disorder (with the exception of nicotine dependence) who require detoxification. Patients who are unable to read and write English or Arabic. Patients having serious, unstable or terminal medical or neurologic illness that would compromise study participation (i.e., metastatic or advanced malignancy, chronic renal failure requiring dialysis, recent myocardial infarction or unstable angina, or "end stage" chronic obstructive pulmonary disease). People with common conditions such as hypertension, insulin dependent diabetes mellitus, asthma, compensated congestive heart failure, a malignancy in remission, treated hypothyroidism, or epilepsy will not be excluded from participation. Autoimmune disease or chronic inflammatory diseases such as psoriasis or Crohn's disease Chronic infection such as hepatitis B or C or HIV Elevated antinuclear antibody or rheumatoid factor Oral glucocorticoids in the past 6 months Methotrexate or NSAID use in the past two weeks

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James H Kocsis, MD

Organizational Affiliation

Weill CMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual Participant Data will not be shared.

Learn more about this trial

Depression, Obesity and Inflammatory Markers

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