DepressionNCT00183755
Understanding Brain Reward Responses in Individuals With Major Depressive Disorder
An observational study of Depression, run by Mclean Hospital at 3 sites in United States.
Trial summary
This study will examine brain responses associated with reinforcement and reward tasks in individuals with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 87 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2005to Apr 2009
- 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
Who may be able to join
- 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 Criteria:
- Left-handed or ambidextrous
- Claustrophobic
- Neurological or medical illness (e.g., attention deficit hyperactivity disorder, head injury, loss of consciousness, seizures)
- Pregnant
Who cannot join
- 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
Show all 24Show fewer
- 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
- 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
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114
Affective Neuroscience Laboratory, Department of Psychology, Harvard University
Cambridge, Massachusetts, 02138
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Neuroimaging Studies of Reward Processing in Depression
This study will examine brain responses associated with reinforcement and reward tasks in individuals with major depressive disorder (MDD).
Read the 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 experience anhedonia, or the inability to gain pleasure from normally pleasurable experiences. Such individuals do not respond to motivational rewards in the same way as do individuals who are not depressed. Anhedonia has been recognized as a core symptom of depression and it is not always remedied with antidepressant medication. Abnormal brain activity and processing may be the underlying cause of depression and specifically anhedonia. A better understanding of the brain mechanisms of depression may lead to the development of new effective medications or psychological treatments.
Event-related potential (ERP), which measures electrical activity in the brain, and functional magnetic resonance imaging (fMRI), which uses scanned images to illustrate changes in brain activity, are two techniques that can identify abnormal areas of brain processing. The purpose of this study is to use ERP and fMRI to compare brain activity that is related to reward processing in individuals with MDD versus individuals without MDD.
This study will consist of 3 study visits; visits will be scheduled as close together as possible. At the first study visit, potential participants will be assessed with the SCID (Structured Clinical Interview for DSM-IV), which will identify individuals with the diagnostic criteria for MDD. A control group of non-depressed individuals will also be enrolled in the study. During the second and third study visits, participants will take part in a monetary reinforcement reward task followed by a signal detection reward task. Brain activity of all participants will be monitored during both tasks. During the second study visit, ERP will be used; during the third study visit, fMRI will be used. Demographic information will also be collected, and participants will complete several standardized questionnaires to assess mood. Some participants will be asked to return after eight weeks to complete the fMRI and EEG sessions again. Those who do complete all five sessions will be awarded a bonus.
- Conditions
- Depression
- Keywords
- Reward Processing, Anhedonia, Major Depressive Disorder, Depression
- Medical subject headings
- Depression, Anhedonia, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Control participants | |
| 2 | Participants with MDD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Given once during the second session for fifteen minutes, and once during the third session for fifteen minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Diego A. Pizzagalli, Mclean Hospital
- Investigators
- Diego A. Pizzagalli, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183755
- Sponsor's protocol ID
- R01MH068376
- Other IDs
- R01MH068376, DATR A3-NSS
- Status last verified
- Apr 2014
- First submitted
- 14 Sep 2005
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19411368
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Studies of Reward Processing in Depression
- ClinicalTrials.gov ID
- NCT00183755
- Acronym / sponsor ID
- R01MH068376
- Conditions
- Depression
- Keywords
- Reward Processing, Anhedonia, Major Depressive Disorder, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 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.
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 experience anhedonia, or the inability to gain pleasure from normally pleasurable experiences. Such individuals do not respond to motivational rewards in the same way as do individuals who are not depressed. Anhedonia has been recognized as a core symptom of depression and it is not always remedied with antidepressant medication. Abnormal brain activity and processing may be the underlying cause of depression and specifically anhedonia. A better understanding of the brain mechanisms of depression may lead to the development of new effective medications or psychological treatments.
Event-related potential (ERP), which measures electrical activity in the brain, and functional magnetic resonance imaging (fMRI), which uses scanned images to illustrate changes in brain activity, are two techniques that can identify abnormal areas of brain processing. The purpose of this study is to use ERP and fMRI to compare brain activity that is related to reward processing in individuals with MDD versus individuals without MDD.
This study will consist of 3 study visits; visits will be scheduled as close together as possible. At the first study visit, potential participants will be assessed with the SCID (Structured Clinical Interview for DSM-IV), which will identify individuals with the diagnostic criteria for MDD. A control group of non-depressed individuals will also be enrolled in the study. During the second and third study visits, participants will take part in a monetary reinforcement reward task followed by a signal detection reward task. Brain activity of all participants will be monitored during both tasks. During the second study visit, ERP will be used; during the third study visit, fMRI will be used. Demographic information will also be collected, and participants will complete several standardized questionnaires to assess mood. Some participants will be asked to return after eight weeks to complete the fMRI and EEG sessions again. Those who do complete all five sessions will be awarded a bonus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Control participants |
| 2 | – | –Participants with MDD |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Control participants, Participants with MDD
Key inclusion criteria (8 listed)
- 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
- Left-handed or ambidextrous
- Claustrophobic
Key exclusion criteria (24 listed)
- 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
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
Performance on Monetary Incentive Delay task
Time frame: Given once during the second session for half an hour, and once during the third session for half an hour
This task features balanced incentive delivery and analytic strategies designed to identify activity specific to anticipation or consumption of incentives.
Signal detection reward task
Time frame: Given once during the second session for fifteen minutes, and once during the third session for fifteen minutes
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.
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 21 Apr 2014.
- Derived from this study: PubMed 19411368Pizzagalli 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.
- Click here for the The Depression Clinical and Research Program, Massachusetts General Hospital web siteLink provided by the sponsor.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Mclean Hospital at 3 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 8 inclusion and 24 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
Performance on Monetary Incentive Delay task (time frame: Given once during the second session for half an hour, and once during the third session for half an hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00183755, which also lists 1 linked publication.
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 21 Apr 2014.