NCT00205933

Brief Summary

The purpose of this project is to use behavioral techniques to investigate emotional processing in subjects with major depression and healthy comparison subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2004

Typical duration for all trials

Geographic Reach
1 country

2 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, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 6, 2007

Status Verified

November 1, 2007

First QC Date

September 13, 2005

Last Update Submit

December 4, 2007

Conditions

Major Depressive DisorderBipolar Disorder

Keywords

DepressionBipolar DisorderReward Processing

Eligibility Criteria

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

Control participants, Participants with MDD, Participants with Bipolar Disorder

You may qualify if:

  • Depressed participants:
  • Right-handed
  • DSM-IV diagnosis of MDD
  • Score of at least 17 on the 21-item HAM-D scale
  • Absence of any psychotropic medications for at least 2 weeks (6 months for dopaminergic drugs (including methylphenidate), 6 weeks for fluoxetine, and 4 weeks for neuroleptics and benzodiazepines because of longer half-lives.)
  • No current or past history of MDD with psychotic features
  • Absence of significant medical conditions
  • Absence of ECT in the previous 6 months
  • Ability to provide informed consent/authorization
  • Bipolar participants:
  • Both genders and all ethnic origins
  • Age between 18 and 64
  • Right-handed
  • DSM-IV diagnosis of Bipolar Disorder I or II
  • Score of at least 17 on the 21-item Hamilton Depression Rating Scale (HAM-D)
  • +11 more criteria

You may not qualify if:

  • Left-handed/ambidextrous
  • Evidence of neurological illness
  • Current alcohol or substance abuse
  • Serious suicide or homicide risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related DisordersBehavioral SymptomsBehavior

Study Officials

  • Diego A Pizzagalli, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2004

Study Completion

June 1, 2007

Last Updated

December 6, 2007

Record last verified: 2007-11

Locations

US(2)