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Neurobehavioral Mechanisms of Emotion Regulation in Depression Across the Adult Lifespan (Lifespan)

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ClinicalTrials.gov Identifier: NCT03207503
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment
Depressive Disorder, Major Procedure: fMRI

Detailed Description:

Emotion regulation capacities are crucial for sustaining mental health in the face of cumulative stressors over one's lifetime. Although it is well documented that some emotion regulation abilities are preserved or even improved in healthy aging, little is known about why regulatory deficits persist in older adults who suffer from depression. Treatments for major depressive disorder (MDD) focus on remediating affective dysregulation processes that confer risks for disability, poor quality of life, and morbidity into late life. Theoretical perspectives on emotional aging propose myriad lifespan changes that potentially impact regulatory capacities, including structural and functional integrity of dorsal attentional and ventral affective processing pathways, cognitive status, and use of specific regulatory strategies, among others. However, there is a dearth of empirical evidence to indicate which combination of these factors critically interacts with depressive symptoms to impact emotional dysregulation in older adults, when these factors become important across the course of the adult lifespan, which strategies they apply to, and whether they can predict future depression status. Thus, the goal of this specific application is to test a comprehensive model of age-related changes to brain circuitry, neurocognitive performance, and social support as predictors of emotion regulation abilities and depressive symptoms in individuals with and without MDD. Reappraisal and distraction are the emotion regulation strategies of primary interest.

Models will be evaluated using primarily a series of linear (multiple) regression models focusing on between-subject effects/comparisons (age, MDD status, etc.) and the emotion regulation outcomes separately for reappraisal and distraction processes. As an extension of these models we will perform Structural Equation Modeling (SEM) type modeling to summarize the liability dimensions underlying the specific domains of depression [BDI scores measuring depression severity; lifetime duration of depressive episode(s)], and neural measures of dorsal attention network functioning [gPPI connectivity between dlPFC and amygdala; task-based activation during distraction in dACC, dlPFC, and inferior parietal lobe; DTI FA measure in SLF II] and affective network functioning [gPPI connectivity between vlPFC and amygdala; task-based activation during reappraisal in vmPFC, vlPFC, and amygdala; DTI FA measure of UF]. The SEM will be especially useful in predicting the future depression that will be assessed at one-year follow up, where the predicted (best linear unbiased predictors-BLUPS) values of lower-dimensional latent traits, along with emotion regulation outcomes, can be used as predictors for future depression. Moreover, hierarchical modeling structures can be imposed on latent traits conditionally on a shared latent trait describing associations among several latent traits thus further reducing underlying dimensionality and simplifying computations. This single trait can be thought as a cumulative effect of all latent traits and can be used a single index of uncertainty in predicting future depression symptom severity.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurobehavioral Mechanisms of Emotion Regulation in Depression Across the Adult Lifespan
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. Success of emotion regulation strategy use. [ Time Frame: baseline ]
    Self-reported negative affect and arousal following the use of reappraisal and distraction strategies

  2. Depression symptom severity [ Time Frame: 6 months ]
    Severity of depressive symptoms as measured by self report

  3. Depression symptom severity [ Time Frame: 12 months ]
    Severity of depressive symptoms as measured by self report



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 MDD and 100 non-depressed (ND) adult qualifying participants ranging in age from 35-75
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207503


Contacts
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Contact: David B Campbell, BA 919-684-6785 dbc6@duke.edu
Contact: Mary Baumann mary.baumann@duke.edu

Locations
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United States, North Carolina
Civitan Building, Duke Psychiatry and Behavioral Sciences Recruiting
Durham, North Carolina, United States, 27705
Contact: David B Campbell, BA    919-684-6785    dbc6@duke.edu   
Contact: Lisalynn Kelley, CCRP    9196846701    lisalynn.kelley@duke.edu   
Psychiatry and Behavioral Services Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: David B Campbell, BA    919-684-6785    dbc@duke.edu   
Contact: Mary Baumann       mary.baumann@duke.edu   
Principal Investigator: Moria J Smoski, Ph.D         
Principal Investigator: Kevin LaBar, Ph.D         
Sub-Investigator: David Madden, Ph.D         
Sub-Investigator: Alaatin Erkanli, Ph.D         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Moria Smoski, PhD Duke Department of Psychiatry
Publications:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03207503    
Other Study ID Numbers: Pro00082070
R01MH113238-1 ( Other Grant/Funding Number: NIMH )
R01MH113238 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This study qualifies as a NDA data sharing study under NIMH guidelines, therefore data will be shared to NDCT.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders