Depressive Disorder, MajorLifespanNCT03207503
Neurobehavioral Mechanisms of Emotion Regulation in Depression Across the Adult Lifespan
An observational study of Depressive Disorder, Major, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- How many people
- 296 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2017to 20 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 MDD and 100 non-depressed (ND) adult qualifying participants ranging in age from 35-75
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Civitan Building, Duke Psychiatry and Behavioral Sciences
Durham, North Carolina, 27705
Psychiatry and Behavioral Services
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- fMRI
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of emotion regulation strategy use.
Self-reported negative affect and arousal following the use of reappraisal and distraction strategies
Measured: baseline
Depression symptom severity
Severity of depressive symptoms as measured by self report
Measured: 6 months
Depression symptom severity
Severity of depressive symptoms as measured by self report
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start10 Oct 2017
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moria Smoski, PhD, Principal investigator, Duke Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207503
- Sponsor's protocol ID
- Pro00082070
- Other IDs
- R01MH113238-1, R01MH113238
- Acronym
- Lifespan
- Status last verified
- Dec 2023
- First submitted
- 30 Jun 2017
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study qualifies as a NDA data sharing study under NIMH guidelines, therefore data will be shared to NDCT.
Publications
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.
PubMed 20044664Winecoff 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.
PubMed 20385663Levenson 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.
PubMed 2029364Knight 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.
PubMed 12507361
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Mechanisms of Emotion Regulation in Depression Across the Adult Lifespan
- ClinicalTrials.gov ID
- NCT03207503
- Acronym / sponsor ID
- Lifespan / Pro00082070
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDD patients | – | Procedure: fMRIParticipants ages 35-75 determined to be clinically depressed via structured clinical interview. No interventions will be administered as part of this study. |
| non-MDD patients | – | Procedure: fMRIParticipants 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 MDD and 100 non-depressed (ND) adult qualifying participants ranging in age from 35-75
Key inclusion criteria (7 listed)
- age 35-75
- No MRI contra-indications (e.g., metal in body)
- Not currently pregnant
- Ambulatory
- No known uncorrected sensory deficits
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIPatients will undergo fMRI imaging to assess areas of the brain that are active during emotion regulation. No clinical benefit of MRI imaging is anticipated. | Procedure or surgery | MDD patients, non-MDD patients |
Primary outcome
Success of emotion regulation strategy use.
Time frame: baseline
Self-reported negative affect and arousal following the use of reappraisal and distraction strategies
Depression symptom severity
Time frame: 6 months
Severity of depressive symptoms as measured by self report
Depression symptom severity
Time frame: 12 months
Severity of depressive symptoms as measured by self report
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 20044664Nienhuis 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.
- Background: PubMed 20385663Winecoff 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.
- Background: PubMed 2029364Levenson 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.
- Background: PubMed 12507361Knight 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.
- Individual participant dataSharing planned: Yes. This study qualifies as a NDA data sharing study under NIMH guidelines, therefore data will be shared to NDCT.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moria Smoski, PhD principal investigator
Duke Department of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of emotion regulation strategy use. (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03207503, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.