Status:

COMPLETED

Understanding Brain Reward Responses in Individuals With Major Depressive Disorder

Lead Sponsor:

Mclean Hospital

Collaborating Sponsors:

National Institute of Mental Health (NIMH)

Conditions:

Depression

Eligibility:

All Genders

18-64 years

Brief Summary

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

Eligibility Criteria

Inclusion

  • Overall
  • 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

  • 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

Key Trial Info

Start Date :

April 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

87 Patients enrolled

Trial Details

Trial ID

NCT00183755

Start Date

April 1 2005

End Date

April 1 2009

Last Update

April 21 2014

Active Locations (3)

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Page 1 of 1 (3 locations)

1

The Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

2

Affective Neuroscience Laboratory, Department of Psychology, Harvard University

Cambridge, Massachusetts, United States, 02138

3

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

Charlestown, Massachusetts, United States, 02129