- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180607
Neuronal Responses to Social Feedback in Major Depressive Disorder
May 27, 2015 updated by: David Hsu, University of Michigan
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Individuals diagnosed with major depressive disorder (MDD), and healthy controls
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy Controls
Response to social feedback, monetary incentive delay, and go/no-go tasks
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MDD patients
Response to social feedback, monetary incentive delay, and go/no-go tasks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fMRI blood-oxygen-level-dependent (BOLD) response
Time Frame: within 30 days of informed consent
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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).
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within 30 days of informed consent
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David T Hsu, Ph.D., University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
June 30, 2014
First Submitted That Met QC Criteria
July 1, 2014
First Posted (Estimate)
July 2, 2014
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01MH085035 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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