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Completed

NCT Number: NCT01426997

Phenotype Depression 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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University Department of Psychiatry and Behavioral Sciences

Atlanta, Georgia, 30322, United States

About this study

One hundred and thiry-five patients with major depression diagnosed based on DSM-IV TR criteria between the ages of 21 and 65 (males, females and minorities) will be recruited. Forty-five patients with high inflammation as defined by a CRP >3 mg/L will be enrolled along with 45 depressed patients with medium inflammation (CRP=1-3mg/L) and 45 depressed patients with low inflammation (CRP<1mg/L) will complete a 2 night inpatient stay in Emory University Hospital's research unit, the Atlanta Clinical and Translational Science Institute (ACTSI). Participants will undergo psychiatric and neurocognitive assessments, sleep studies and blood and cerebral spinal fluid (CSF) sampling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: Inpatient visit

    Behavior: Hamilton Depression Rating Scale (HAM-D); Inventory of Depressive Symptoms-Self Report (IDS-SR); Salpetriere Retardation Rating Scale (SRRS); Snaith-Hamilton Pleasure Scale (SHAPS); Multidimensional Fatigue Inventory (MFI); Neuropsychology: Finger tapping task; Reaction Time Task (CANTAB); Trial Making Test, Part A; Digit Symbol Test; Stocking of Cambridge

Secondary outcomes

  1. 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.

    Time frame: Inpatient visit; Day #2

    Immune Markers: plasma and CSF IFN-alpha, IL-6, sIL-6R, TNF-alpha, sTNFR 1 and 2, IL-1 beta, IL-1ra, sIL-2R and MCP-1; PBMC mRNA expression of genes with responsive elements for NF-kB and MAPK gene expression as well as intracellular phosphorylated p38 as determined by flow cytometry; polymorphisms in genes encoding for IL-1, IL-6, TNF-alpha (and their soluble receptors) as well as MCP-1

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Phenotyping Major Depression With Increased Inflammation

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2011
Registry last updated
Jun 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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