Depression, Obesity and Inflammatory Markers

NCT02765100 | Completed Results

• 1 other identifier: 1406015184
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Depression; Obesity

Keywords

Bipolar Disorder; Obesity; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline; week 8

Study Arms (2)

Low CRP

EXPERIMENTAL

Subjects have CRP \> 3

Drug: Minocycline

High CRP

EXPERIMENTAL

Subjects have CRP =/\> 3

Drug: Minocycline

Interventions

Minocycline DRUG

Minocycline 100 mg twice a day

Also known as: Minocin

High CRP; Low CRP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Fluent in English or Arabic
• Have the capacity to understand the nature of the study and sign the written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Weill Cornell Medical College in Qatar: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression; Obesity

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: James H Kocsis, M.D.
• Organization: Weill Cornell Medicine

jhk2002@med.cornell.edu

212-746-5913

Study Officials

• James H Kocsis, MD

  Weill CMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 6, 2016
• Study Start: October 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 1, 2020
• Results First Posted: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)