Understanding Brain Reward Responses in Individuals With Major Depressive Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183755

Purpose

This study will examine brain responses associated with reinforcement and reward tasks in individuals with major depressive disorder (MDD).

Condition
Depression

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Neuroimaging Studies of Reward Processing in Depression

Further study details as provided by National Institute of Mental Health (NIMH):

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	68
Study Start Date:	April 2005
Estimated Study Completion Date:	April 2009

Groups/Cohorts
1 Control participants
2 Participants with MDD

Detailed Description:

Major depressive disorder (MDD) is a severe form of depression that can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD may experience anhedonia, or the inability to gain pleasure from normally pleasurable experiences. Such individuals do not respond to motivational rewards in the same way as do individuals who are not depressed. Anhedonia has been recognized as a core symptom of depression and it is not always remedied with antidepressant medication. Abnormal brain activity and processing may be the underlying cause of depression and specifically anhedonia. A better understanding of the brain mechanisms of depression may lead to the development of new effective medications or psychological treatments.

Event-related potential (ERP), which measures electrical activity in the brain, and functional magnetic resonance imaging (fMRI), which uses scanned images to illustrate changes in brain activity, are two techniques that can identify abnormal areas of brain processing. The purpose of this study is to use ERP and fMRI to compare brain activity that is related to reward processing in individuals with MDD versus individuals without MDD.

This study will consist of 3 study visits; visits will be scheduled as close together as possible. At the first study visit, potential participants will be assessed with the SCID (Structured Clinical Interview for DSM-IV), which will identify individuals with the diagnostic criteria for MDD. A control group of non-depressed individuals will also be enrolled in the study. During the second and third study visits, participants will take part in a monetary reinforcement reward task followed by a signal detection reward task. Brain activity of all participants will be monitored during both tasks. During the second study visit, ERP will be used; during the third study visit, fMRI will be used. Demographic information will also be collected, and participants will complete several standardized questionnaires to assess mood. Some participants will be asked to return after eight weeks to complete the fMRI and EEG sessions again. Those who do complete all five sessions will be awarded a bonus.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Control participants, Participants with MDD

Criteria

Overall Inclusion Criteria:

Right-handed
Agrees to use an effective form of contraception throughout the study

Inclusion Criteria for Depressed Participants:

Meets overall inclusion criteria
Meets DSM-IV diagnosis criteria for major depressive disorder
Score of at least 16 on the 21-item HAM-D scale

Overall Exclusion Criteria:

Left-handed or ambidextrous
Claustrophobic
Neurological or medical illness (e.g., attention deficit hyperactivity disorder, head injury, loss of consciousness, seizures)
Pregnant

Exclusion Criteria for Depressed Participants:

Meets any of the overall exclusion criteria
Has been treated with electroconvulsive therapy within 6 months of study entry
Has taken any benzodiazepine medications for at least 2 weeks prior to study entry and discontinued use of the medication for reasons other than participating in the study
Has taken any dopaminergic medications (including methylphenidate) or neuroleptics for at least 6 months prior to study entry and discontinued use of the medication for reasons other than participating in the study
Has taken any fluoxetine medications for at least 6 weeks prior to study entry and discontinued use of the medication for reasons other than participating in the study
Has taken any medications that may have antidepressant properties (including some herbal supplements) within 2 weeks of study entry
Has taken any medications that may affect blood flow (including some blood pressure medications) within 2 weeks of study entry
Current or past history of MDD with psychotic features
Meets DSM-IV diagnosis criteria for organic mental disorder; substance use disorder (within 1 year of study entry); lifetime substance dependence; schizophrenia; delusional disorder; bipolar disorder; post-traumatic stress disorder; eating disorder; acute bereavement; severe borderline or antisocial personality disorder; or any psychotic disorder not otherwise specified
Current primary diagnosis of panic disorder, social phobia, generalized anxiety disorder, obsessive-compulsive disorder, or somatoform disorder

Exclusion Criteria for Control Participants

Meets any of the overall exclusion criteria
Diagnosed with any medical or neurological illness
Diagnosed with any current or past psychiatric illness, as assessed by the SCID-I, including substance abuse or dependence (e.g., alcohol)
Has taken any medications that may have antidepressant properties (including some herbal supplements) within 2 weeks of study entry
Has taken any psychotropic medications within 2 weeks of study entry
Has taken any medications that may affect blood flow (including some blood pressure medications) within 2 weeks of study entry

Exclusion Criteria for fMRI Studies:

Meets any of the overall exclusion criteria
Fails to meet safety standards for fMRI
Current back problems
Has strongly corrected vision, but does not wear contact lenses
Weighs more than 250 pounds or exceeds the limit of height-to-weight ratio for a comfortable fit in the scanner
Pregnant
Current alcohol or substance abuse
At risk for suicide or homicide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183755

Contacts

Contact: Diego A. Pizzagalli, PhD	617-496-8896	dap@wjh.harvard.edu
Contact: Sunny J. Dutra, BA	617-384-9841	sdutra@wjh.harvard.edu

Locations

United States, Massachusetts
Affective Neuroscience Laboratory, Department of Psychology, Harvard University	Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Elena L. Goetz, BA 617-384-9841 egoetz@wjh.harvard.edu
Principal Investigator: Diego A. Pizzagalli, PhD
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital	Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Elena L. Goetz, BA 617-384-9841 egoetz@wjh.harvard.edu
Principal Investigator: Darin D. Dougherty, MD
The Depression Clinical and Research Program, Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Adrienne Van Nieuwenhuizen, BA 617-724-3222 avannieuwenhuizen@partners.org
Sub-Investigator: Maurizio Fava, MD
Sub-Investigator: Dan Iosifescu, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Diego A. Pizzagalli, PhD

Harvard University

More Information

Click here for the Affective Neuroscience Laboratory, Department of Psychology, Harvard University web site This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Click here for the The Depression Clinical and Research Program, Massachusetts General Hospital web site This link exits the ClinicalTrials.gov site

Click here for the Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital web site This link exits the ClinicalTrials.gov site

Responsible Party:	Harvard University ( Diego Pizzagalli, John and Ruth Hazel Associate Professor of the Social Sciences )
Study ID Numbers:	R01 MH68376, DATR A3-NSS
Study First Received:	September 14, 2005
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00183755
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Reward Processing
Anhedonia
Major Depressive Disorder
Depression

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 15, 2009