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Trial record 12 of 26 for:    inflammation | Bipolar Disorder

Depression, Obesity and Inflammatory Markers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02765100
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Weill Cornell Medical College in Qatar
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The purpose of this study is to better understand the relationship between bipolar disorder, body weight, and inflammation in the body. People with bipolar depression 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression Obesity Drug: Minocycline Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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.
Drug: Minocycline
In various models of neurodegenerative disease, minocycline has demonstrated neurorestorative as well as neuroprotective properties.
Other Name: Minocin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hamilton Depression Scale change score [ Time Frame: 6 weeks ]
    Scale ranges from 0-65, greater change is better



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Weill Cornell Medical College in Qatar
Investigators
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Principal Investigator: James H Kocsis, MD Weill CMC

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02765100    
Other Study ID Numbers: 1406015184
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared.
Keywords provided by Weill Medical College of Cornell University:
Bipolar Disorder
Obesity
Depression
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Nutrition Disorders
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Obesity
Depression
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Behavioral Symptoms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents