NCT00183755

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

4 years

First QC Date

September 14, 2005

Last Update Submit

April 16, 2014

Conditions

Keywords

Reward ProcessingAnhedoniaMajor Depressive DisorderDepression

Outcome Measures

Primary Outcomes (2)

  • Performance on Monetary Incentive Delay task

    This task features balanced incentive delivery and analytic strategies designed to identify activity specific to anticipation or consumption of incentives.

    Given once during the second session for half an hour, and once during the third session for half an hour

  • Signal detection reward task

    This reward task provides an objective assessment of hedonic capacity. Due to the probabilistic nature of the task, participants cannot infer which stimulus is more advantageous based on the outcome of single trials but need to integrate reinforcement history over time to optimize behavior.

    Given once during the second session for fifteen minutes, and once during the third session for fifteen minutes

Study Arms (2)

1

Control participants

2

Participants with MDD

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Control participants, Participants with MDD

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Affective Neuroscience Laboratory, Department of Psychology, Harvard University

Cambridge, Massachusetts, 02138, United States

Location

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

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnhedoniaDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Diego A. Pizzagalli, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Harvard Medical School

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

April 1, 2005

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations