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

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

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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
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 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
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).
within 30 days of informed consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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