Understanding Brain Reward Responses in Individuals With Major Depressive Disorder

NCT ID: NCT00183755

Last Updated: 2014-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Control participants

No interventions assigned to this group

2

Participants with MDD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

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


* 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


* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Diego A. Pizzagalli

Associate Professor, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diego A. Pizzagalli, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

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The Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Affective Neuroscience Laboratory, Department of Psychology, Harvard University

Cambridge, Massachusetts, United States

Site Status

Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

References

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Pizzagalli DA, Holmes AJ, Dillon DG, Goetz EL, Birk JL, Bogdan R, Dougherty DD, Iosifescu DV, Rauch SL, Fava M. Reduced caudate and nucleus accumbens response to rewards in unmedicated individuals with major depressive disorder. Am J Psychiatry. 2009 Jun;166(6):702-10. doi: 10.1176/appi.ajp.2008.08081201. Epub 2009 May 1.

Reference Type DERIVED
PMID: 19411368 (View on PubMed)

Other Identifiers

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R01MH068376

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DATR A3-NSS

Identifier Type: -

Identifier Source: secondary_id

R01MH068376

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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