Neurobehavioral Mechanisms of Emotion Regulation in Depression Across the Adult Lifespan

NCT03207503 | Completed

• 3 other identifiers: Pro00082070R01MH113238-1R01MH113238
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to test a model of demographic (age, sex), clinical, cognitive, and neurocircuitry predictors of emotion regulation ability and long-term depressive symptoms.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (3)

• Success of emotion regulation strategy use.

  Self-reported negative affect and arousal following the use of reappraisal and distraction strategies

  baseline

• Depression symptom severity

  Severity of depressive symptoms as measured by self report

  6 months

• Depression symptom severity

  Severity of depressive symptoms as measured by self report

  12 months

Study Arms (2)

MDD patients

Participants ages 35-75 determined to be clinically depressed via structured clinical interview. No interventions will be administered as part of this study.

Procedure: fMRI

non-MDD patients

Participants ages 35-75 determined to be lifetime free of psychiatric conditions as assessed by structured clinical interview. No interventions will be administered as part of this study.

Procedure: fMRI

Interventions

fMRI PROCEDURE

Patients will undergo fMRI imaging to assess areas of the brain that are active during emotion regulation. No clinical benefit of MRI imaging is anticipated.

MDD patients; non-MDD patients

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 MDD and 100 non-depressed (ND) adult qualifying participants ranging in age from 35-75

You may qualify if:

• age 35-75
• No MRI contra-indications (e.g., metal in body)
• Not currently pregnant
• Ambulatory
• No known uncorrected sensory deficits
• Estimated verbal IQ of 85+ as indicated by the North American Adult Reading test MDD group: Current MDD assessed by history of MDD as assessed by standardized SCID interview
• Control Group: no lifetime of history of MDD as assessed by standardized SCID interview

You may not qualify if:

• History of moderate or severe substance dependence, as assessed by standardized SCID interview
• History of psychosis, mania, or eating disorders, as assessed by standardized SCID interview
• Disorders with impact on brain characteristics (e.g., epilepsy, Parkinson's Disease) or history of stroke
• Contraindications to MRI scanning, as indicated on the MRI safety screening questionnaire
• Use of antidepressants or other psychotropics other than sleep aids in the past 4 weeks (8 weeks for fluoxetine)
• Indication of mild cognitive impairment or dementia. To meet screening criteria, participants must meet all of the following:
• Scoring of 24 or higher on the Montreal Cognitive Assessment;
• perform above 1.5 standard deviations on the following measures: HVLT delayed recall, Trail Making B, and Animal Naming based normative values

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Civitan Building, Duke Psychiatry and Behavioral Sciences

Durham, North Carolina, 27705, United States

Location

Psychiatry and Behavioral Services

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

• Nienhuis FJ, van de Willige G, Rijnders CA, de Jonge P, Wiersma D. Validity of a short clinical interview for psychiatric diagnosis: the mini-SCAN. Br J Psychiatry. 2010 Jan;196(1):64-8. doi: 10.1192/bjp.bp.109.066563.

  PMID: 20044664 BACKGROUND

• Winecoff A, Labar KS, Madden DJ, Cabeza R, Huettel SA. Cognitive and neural contributors to emotion regulation in aging. Soc Cogn Affect Neurosci. 2011 Apr;6(2):165-76. doi: 10.1093/scan/nsq030. Epub 2010 Apr 12.

  PMID: 20385663 BACKGROUND

• Levenson RW, Carstensen LL, Friesen WV, Ekman P. Emotion, physiology, and expression in old age. Psychol Aging. 1991 Mar;6(1):28-35. doi: 10.1037//0882-7974.6.1.28.

  PMID: 2029364 BACKGROUND

• Knight BG, Maines ML, Robinson GS. The effects of sad mood on memory in older adults: a test of the mood congruence effect. Psychol Aging. 2002 Dec;17(4):653-61. doi: 10.1037//0882-7974.17.4.653.

  PMID: 12507361 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Moria Smoski, PhD

  Duke Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: October 10, 2017
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)