Phenotype Depression Study

NCT01426997 | Completed DMC

• 2 other identifiers: IRB000391071R01MH087604-01A1
• Study Type: observational
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Depression

Outcome Measures

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.

  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

  Inpatient visit

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.

  Inpatient visit; Day #2

Study Arms (3)

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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University Department of Psychiatry and Behavioral Sciences

Atlanta, Georgia, 30322, United States

Location

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.

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Andrew H. Miller, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: July 1, 2010
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)