Major Depressive DisorderNCT00205933
Behavioral Processes Underlying Reward Processing in Depression
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Affective Neuroscience Laboratory at 2 sites in United States.
Trial summary
The purpose of this project is to use behavioral techniques to investigate emotional processing in subjects with major depression and healthy comparison subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2004to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Control participants, Participants with MDD, Participants with Bipolar Disorder
Who may be able to join
- 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
Show all 27Show fewer
- 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
Who cannot join
- Left-handed/ambidextrous
- Evidence of neurological illness
- Current alcohol or substance abuse
- Serious suicide or homicide risk
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114
Affective Neuroscience Laboratory, Department of Psychology, Harvard University
Cambridge, Massachusetts, 02138
About this study
The purpose of this project is to use behavioral techniques to investigate emotional processing in subjects with major depression and healthy comparison subjects.
Read the detailed description
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
- Major Depressive Disorder, Bipolar Disorder
- Keywords
- Depression, Bipolar Disorder, Reward Processing
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affective Neuroscience Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Investigators
- Diego A Pizzagalli, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205933
- Sponsor's protocol ID
- 2003-P-000994
- Status last verified
- Nov 2007
- First submitted
- 13 Sep 2005
- Last updated
- 6 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Processes Underlying Reward Processing in Depression
- ClinicalTrials.gov ID
- NCT00205933
- Acronym / sponsor ID
- 2003-P-000994
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Keywords
- Depression, Bipolar Disorder, Reward Processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Affective Neuroscience LaboratoryUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Apr 2004
- Study completion
- Jun 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Control participants, Participants with MDD, Participants with Bipolar Disorder
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (4 listed)
- Left-handed/ambidextrous
- Evidence of neurological illness
- Current alcohol or substance abuse
- Serious suicide or homicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego A Pizzagalli, PhD principal investigator
Harvard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Affective Neuroscience Laboratory at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2007.