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.
Major Depressive Disorder
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Phenotyping Major Depression With Increased Inflammation|
- 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
- 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.
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426997
|United States, Georgia|
|Emory University Department of Psychiatry and Behavioral Sciences|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Andrew H. Miller, MD||Emory University|