Phenotype Depression Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrew H Miller, Emory University
ClinicalTrials.gov Identifier:
NCT01426997
First received: August 30, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Phenotyping Major Depression With Increased Inflammation

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

Diurnal plasma samples are collected hourly from 9 am to 9 pm once; Cerebrospinal fluid once; mRNA from peripheral blood leuckocytes collected 5 times; DNA for analysis of genetic polymorphisms is collected once.


Estimated Enrollment: 135
Study Start Date: July 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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)

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426997

Contacts
Contact: Bobbi J. Woolwine, MSW 404-712-9620 bwoolwi@emory.edu

Locations
United States, Georgia
Emory University Department of Psychiatry and Behavioral Sciences Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bobbi J. Woolwine, MSW    404-712-9620    bwoolwi@emory.edu   
Sub-Investigator: Charles L. Raison, MD         
Sub-Investigator: Ebrahim Haroon, MD         
Sub-Investigator: Bobbi J. Woolwine, MSW         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Andrew H. Miller, MD Emory University
  More Information

No publications provided

Responsible Party: Andrew H Miller, Professor, Psychiatry and Behavioral Sciences, Emory University
ClinicalTrials.gov Identifier: NCT01426997     History of Changes
Other Study ID Numbers: IRB00039107, 1R01MH087604-01A1
Study First Received: August 30, 2011
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Major Depressive Disorder
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014