Behavioral Processes Underlying Reward Processing in Depression

NCT ID: NCT00205933

Last Updated: 2007-12-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A promising strategy for parsing the heterogeneity of Major Depressive Disorder is to identify phenotypes characterized by reliable functional abnormalities. Anhedonia, the lack of reactivity to pleasurable stimuli, is considered a trait marker for depression. Using an objective behavioral task this project aims to investigate hedonic capacity in subjects meeting a DSM-IV diagnosis of Major Depressive Disorder.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder Bipolar Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depression Bipolar Disorder Reward Processing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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 any other Axis I or Axis II diagnosis (Including bipolar disorder and current or lifetime history of alcohol or substance abuse or dependence.) Particularly, subjects with a history of alcoholism and substance abuse will be excluded, since dopaminergic alterations have been reported in these conditions. Exclusion of patients with comorbid Axis I or Axis II diagnoses will be necessary as evidence exists of alteration in dopamine receptor density in detached personality and social phobia. The alteration of dopamine in the brain may in turn alter behavior.
* 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)
* 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 any other Axis I or Axis II diagnosis (Including current or lifetime history of alcohol or substance abuse or dependence.) Particularly, subjects with a history of alcoholism and substance abuse will be excluded.
* Absence of significant medical conditions
* Absence of ECT in the previous 6 months
* Ability to provide informed consent/authorization

Control Participants:

* Right-handed
* Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by the SCID
* Absence of any medications for at least 2 weeks
* Informed consent/authorization

Exclusion Criteria

* Left-handed/ambidextrous
* Evidence of neurological illness
* Current alcohol or substance abuse
* Serious suicide or homicide risk
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Affective Neuroscience Laboratory

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Harvard University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diego A Pizzagalli, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2003-P-000994

Identifier Type: -

Identifier Source: org_study_id