Major Depressive DisorderNCT02180607
Neuronal Responses to Social Feedback in Major Depressive Disorder
An observational study of Major Depressive Disorder, run by University of Michigan at 1 site in United States.
Trial summary
The overall goal of the proposed project is to investigate the neuronal pathways regulating the effects of social acceptance and rejection in healthy controls and patients with Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2014
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals diagnosed with major depressive disorder (MDD), and healthy controls
Who may be able to join
- Men and women between 18 and 55 years of age
- No use of psychotropic medications in the past 4 weeks
- No regular tobacco use, and who are able to make decisions for his or her self -Patients who meet criteria for (DSM-IV) Major Depressive Disorder or Depressive Disorder Not Otherwise Specified, with Hamilton Depression Rating Scale scores ≥ 10, and may be on monotherapy (treatment for MDD with a single SSRI)
- MDD patients will be matched with healthy controls for age and education.
Who cannot join
- No serious medical illnesses or major physiological disturbance during the past three months (e.g., serious infections or pregnancy) or anemia Any other Axis I psychiatric disorder
- Pharmacological exclusion criteria include the use of psychoactive substances during past 3 months (e.g., barbiturates, anticonvulsants glutethimide, alpha-methyl dopa, corticosteroids [oral or topical creams], opiates or codeine, cyproheptadine, opioid analgesics, antipsychotic drugs)
- History of DSM-IV alcohol or drug dependence within the past 5 years
- Drug or alcohol abuse in the past 2 years or a CAGE Alcohol Screening Inventory score of >3
- Regular alcohol use during the past 6 months equal to or greater than 16 cans of beer per week or equivalent; use of street drugs during the past 2 years
- Regular tobacco use, since nicotine stimulates cortisol secretion even in smokers;
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- Major chronobiological disruption or phase shift during the preceding month (e.g., total sleep deprivation, reversal of sleep-wake cycles or trans-meridian travel)
- Childbirth or miscarriage within 6 months
- Breastfeeding within 6 months of recruitment
- Progestin-only birth controls (e.g., Cerazette, Ovrette)
- No contraindications to MRI scan including neurostimulators, metal in the body, weight over 250 pounds, and girth size incompatible for MRI scanner bore
- No non-right-handed subjects
- For healthy controls, subjects will have no history of psychiatric problems in themselves or any first-degree relatives
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of the proposed project is to investigate the neuronal pathways regulating the effects of social acceptance and rejection in healthy controls and patients with Major Depressive Disorder (MDD). Social acceptance and rejection are defined as the explicit declaration that an individual is liked or not liked. Social acceptance can boost one's self-esteem and mood, whereas rejection can lower them. The neurological relationship between social acceptance/rejection and depressive symptoms is not known. Using functional magnetic resonance imaging (fMRI), it is hypothesized that social feedback will activate a specific interconnected neuronal pathway involved in social separation and reward. Executive functioning and response to monetary reward will also be assessed during fMRI using two additional tasks (monetary incentive delay, parametric go no-go) to determine how these cognitive brain functions regulate responses to social feedback.
- Conditions
- Major Depressive Disorder
- Keywords
- depression, social, rejection, acceptance, fMRI, reward, exclusion
- Medical subject headings
- Depressive Disorder, Major, Depression, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Response to social feedback, monetary incentive delay, and go/no-go tasks | |
| MDD patients | Response to social feedback, monetary incentive delay, and go/no-go tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI blood-oxygen-level-dependent (BOLD) response
This study will compare brain activation in healthy and depressed individuals in response to social feedback, monetary reward, and behavioral inhibition. Primary regions of interest include: the amygdala, anterior insular cortex, and the nucleus accumbens. All structures will be examined bilaterally. Arbitrary units for fMRI BOLD are used to compare activation during one condition (e.g., neutral, baseline) vs. another condition (e.g., positive social feedback, monetary reward).
Measured: within 30 days of informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Hsu, University of Michigan
- Investigators
- David T Hsu, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180607
- Sponsor's protocol ID
- K01MH085035
- Status last verified
- May 2015
- First submitted
- 30 Jun 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Responses to Social Feedback in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02180607
- Acronym / sponsor ID
- K01MH085035
- Conditions
- Major Depressive Disorder
- Keywords
- depression, social, rejection, acceptance, fMRI, reward, exclusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 2 Jul 2014 (estimated)
- 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 overall goal of the proposed project is to investigate the neuronal pathways regulating the effects of social acceptance and rejection in healthy controls and patients with Major Depressive Disorder (MDD). Social acceptance and rejection are defined as the explicit declaration that an individual is liked or not liked. Social acceptance can boost one's self-esteem and mood, whereas rejection can lower them. The neurological relationship between social acceptance/rejection and depressive symptoms is not known. Using functional magnetic resonance imaging (fMRI), it is hypothesized that social feedback will activate a specific interconnected neuronal pathway involved in social separation and reward. Executive functioning and response to monetary reward will also be assessed during fMRI using two additional tasks (monetary incentive delay, parametric go no-go) to determine how these cognitive brain functions regulate responses to social feedback.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Response to social feedback, monetary incentive delay, and go/no-go tasks |
| MDD patients | – | –Response to social feedback, monetary incentive delay, and go/no-go tasks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals diagnosed with major depressive disorder (MDD), and healthy controls
Key inclusion criteria (4 listed)
- Men and women between 18 and 55 years of age
- No use of psychotropic medications in the past 4 weeks
- No regular tobacco use, and who are able to make decisions for his or her self -Patients who meet criteria for (DSM-IV) Major Depressive Disorder or Depressive Disorder Not Otherwise Specified, with Hamilton Depression Rating Scale scores ≥ 10, and may be on monotherapy (treatment for MDD with a single SSRI)
- MDD patients will be matched with healthy controls for age and education.
Key exclusion criteria (13 listed)
- No serious medical illnesses or major physiological disturbance during the past three months (e.g., serious infections or pregnancy) or anemia Any other Axis I psychiatric disorder
- Pharmacological exclusion criteria include the use of psychoactive substances during past 3 months (e.g., barbiturates, anticonvulsants glutethimide, alpha-methyl dopa, corticosteroids [oral or topical creams], opiates or codeine, cyproheptadine, opioid analgesics, antipsychotic drugs)
- History of DSM-IV alcohol or drug dependence within the past 5 years
- Drug or alcohol abuse in the past 2 years or a CAGE Alcohol Screening Inventory score of >3
- Regular alcohol use during the past 6 months equal to or greater than 16 cans of beer per week or equivalent; use of street drugs during the past 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fMRI blood-oxygen-level-dependent (BOLD) response
Time frame: within 30 days of informed consent
This study will compare brain activation in healthy and depressed individuals in response to social feedback, monetary reward, and behavioral inhibition. Primary regions of interest include: the amygdala, anterior insular cortex, and the nucleus accumbens. All structures will be examined bilaterally. Arbitrary units for fMRI BOLD are used to compare activation during one condition (e.g., neutral, baseline) vs. another condition (e.g., positive social feedback, monetary reward).
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 28 May 2015.
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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.
David T Hsu, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by University of Michigan at 1 site 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 4 inclusion and 13 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
fMRI blood-oxygen-level-dependent (BOLD) response (time frame: within 30 days of informed consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2015; AzTrials last refreshed its copy on 7 Nov 2026.