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Major Depressive Disorder | Phenotype Depression Study

Major Depressive Disorder research study

What is the primary objective of this study?

To facilitate the development of a personalized approach to the treatment of patients with major depression, this study is designed to elaborate the clinical and neurobiological phenotype of depressed patients with increased inflammation. The data obtained in this proposal will allow the investigators to test the hypothesis that depression and inflammation interact to elaborate a relatively discreet phenotype that warrants an individualized approach to diagnosis and treatment of patients with depression. Moreover, the identification of specific environmental risk factors for inflammation will foster the elaboration of preventative strategies for patients at risk.

Who is eligible to participate?

Inclusion Criteria: - age 21-65 years including males, females and minorities - diagnosis of DSM-IV major depression or Bipolar I or II with current episode of depression - HDRS-17 > 20 and HDRS-24 > 24 - negative pregnancy test for women of childbearing potential - not breast feeding - stable on current dose of psychotropic medication or free from all psychotropic medications for 4 weeks prior to EUH CIN admission (8 weeks for fluoxetine) - no suicide attempt within six months of screening Exclusion Criteria: - evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease - history of CNS trauma or active seizure disorder requiring medication unless otherwise approved by principle investigator - autoimmune or inflammatory disorder of any kind - chronic infection (e.g. hepatitis B or C or HIV) - chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 1 year, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) (within the past 2 weeks) and statins (within the past 1 month) unless otherwise approved by principle investigator - hemoglobinopathies (e.g. thalassemia) - a positive pregnancy test - organ transplants - cancer of any type - a score of <28 on the Mini Mental Status Exam (MMSE)unless otherwise approved by principle investigator - meets criteria for schizophrenia (Given overlap of generalized anxiety disorder (GAD) with major depression, GAD will not be exclusionary) - current eating disorders - active abuse of alcohol or illicit/prescription drugs within the past year unless otherwise approved by principle investigator. - MGH-S >3 unless otherwise approved by principle investigator - BMI >40 unless otherwise approved by the principle investigator - active suicidal intent or plan and a score >2 on the HDRS suicide item (item #3). - any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

High inflammation group (CRP>3 mg/L)Forty-five participants each with a diagnosis of major depressive disorder and a CRP level >3 mg/L

Medium inflammation group (CRP=1-3 mg/L)Forty-five participants each with a diagnosis of major depressive disorder and a CRP level = 1-3 mg/L

Low inflammation group (CRP<1 mg/L).Forty-five participants each with a diagnosis of major depressive disorder and a CRP level <1 mg/L

Study Status

Completed

Start Date: July 2010

Completed Date: May 2016

Phase:

Type: Observational

Design:

Primary Outcome: We are using clinician administered and self report psychiatric measurements to compare relevant symptom domains in patients with major depression and increased inflammation versus patients with major depression without increased inflammation.

Secondary Outcome: We are measuring immune markers for the identification of relevant immunologic patterns of activation in patients with major depression and increased inflammation versus patients with major depression without increased inflammation.

Study sponsors, principal investigator, and references

Principal Investigator: Andrew H. Miller, MD

Lead Sponsor: Emory University

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT01426997

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