Systemic Inflammation Related to Mood Disorders

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-002948
    Sponsor Protocol Number: 17-002948

About this study

The overall goal is to better understand the underlying pathophysiology of mood disorders and bipolar disorders in particular. We aim to investigate whether the subclinical atherosclerotic and inflammatory markers differ between patients with bipolar disorder, major depressive disorder, and psychiatric non-mood disorders and healthy subjects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion criteria:

Bipolar disorder group

  • Age 25-60 years
  • Male/female
  • Any race/ethnicity
  • Diagnosis of BD confirmed by mini international neuropsychiatric interview (M.I.N.I)

Major depressive disorder group

  • Diagnosis of MDD confirmed by mini international neuropsychiatric interview (M.I.N.I)

Non-mood psychiatric disorder control group

  • Diagnosis of psychiatric disorder confirmed by mini international neuropsychiatric interview (M.I.N.I)

Healthy control group

Exclusion criteria

General

  • Inability to speak English
  • Inability or lack of willingness to provide informed consent
  • Unstable medical condition
  • Pregnancy
  • BMI > 35
  • History of atherosclerotic cardiovascular disease including myocardial infarction, stable/unstable angina, coronary or other arterial revascularization, stroke/ transient ischemic attack and peripheral artery disease.
  • Family history of premature cardiovascular disease in first degree relatives (age less than 55 years for males and 65 years for females).
  • Diabetes mellitus type I and II
  • Hypertension out of control
  • LDL-cholesterol > 190
  • Active infection such as HIV, Hepatitis B and Hepatitis C
  • Inflammatory disease including inflammatory bowel disease, systemic lupus erythematous and rheumatoid arthritis
  • Nephrotic or nephritic syndrome or patients with renal diseases that are undergoing dialysis
  • Receiving statins, antibiotics, anti-inflammatory (not including NSAIDs) or immunosuppressive drugs

Group Specified

  • Psychiatric disorder other than BD as primary diagnosis
  • Active mania
  • Psychiatric disorder other than MDD as primary diagnosis
  • Active psychosis and/or suicidal ideation
  • Presence of BD or MDD as assessed M.I.N.I
  • Active psychosis and/or suicidal ideation
  • Presence of BD or MDD as assessed by M.I.N.I
  • Family history of BD in first degree relative

 

 

 

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Morgan, M.D., Ph.D.

Open for enrollment

Contact information:

Moein Foroughi Nematollahi

(507)284-3352

Foroughi.Moein@mayo.edu

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CLS-20320340

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