Neural SystemsNCT00352456
Psychological Mechanisms of Behavioral Dysregulation
An observational study of Neural Systems and Psychopathology, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study is directed toward a better understanding of how the brain regulates emotions and social and antisocial behavior. It will look at the use of the orbital frontal cortex and amygdala of the brain. Brain changes are involved in solving conflicts and the feelings that such conflicts produce. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neural Systems, Psychopathology
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2004to 21 Apr 2008
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Psychopathy:
- Comparison individuals: All individuals will score less than 20 on the PCL-R.
- Individuals with psychopathy: All individuals will score more than 30 on the PCL-R (participants scoring between 21-29 are excluded from study participation).
- Age: Participants will be males and females, 20-50 years of age.
- IQ: IQ, as measured by 4 subscales from the Wechsler Adult Intelligence Scale-Revised (WAIS-R), must be greater than 80.
- Medication status: No current use of any psychotropic medication or benzodiazepine.
Who cannot join
- Because factors such as psychiatric disease, or CNS disease, can influence functional brain activity, these factors are exclusionary.
- Psychiatric history: Participants will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (i.e., SCID).
- Comparison individuals: All participants will be free of any current or past psychiatric disorder. Participants will be excluded if they meet criteria for substance dependence but not if they meet criteria for substance abuse.
- Individuals with psychopathy: It is to be expected that the individuals with psychopathy will meet diagnostic criteria for Antisocial Personality Disorder and, in childhood, would have met criteria for Conduct Disorder, Oppositional Defiant Disorder and probably Attentional Deficit and Hyperactivity Disorder. Any other current or past psychiatric disorder will be exclusory. Participants will be excluded if they meet criteria for substance dependence but not if they meet criteria for substance abuse.
- Severe acute and chronic medical illnesses. In short, any condition requiring the administration of systemic drugs will be exclusory.
- CNS disease: history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, or history of head trauma (defined as loss of consciousness greater than 3 min).
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- Metal or electronic objects: Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
- Claustrophobia: participants will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.
- There will be no exclusion criteria as regards type of crime. While there is some increase in risk to testers in having participants who have committed acts of violence, it is not extreme as long as the participants are appropriately treated. Indeed, in our previous work almost all of our participants (comparison individuals and individuals with psychopathy) were murderers.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Psychobiological Mechanisms of Behavioral Dysregulation
This study is directed toward a better understanding of how the brain regulates emotions and social and antisocial behavior. It will look at the use of the orbital frontal cortex and amygdala of the brain. Brain changes are involved in solving conflicts and the feelings that such conflicts produce. Conflicts may occur with other people or with general social rules. The researchers' expectations are that the findings will be useful in developing therapies that may improve people's ability to solve social conflicts and reduce antisocial behavior.
Adults ages 20 to 50 years of age with psychopathy and a second set of comparison adults, all of whom have been released from the Fairfax County Adult Detention Center, may be eligible for this study.
Read more
The neurocognitive component of the study, the one pertaining to performance of various tasks, will involve 20 adults with psychopathy and 20 comparison adults. The neuroimaging component, in which a magnetic resonance imaging (MRI) scan is used, will involve 18 adults and 18 comparison adults. Two visits by participants will be entailed. At the first visit, patients will undergo the following procedures and tests:
- Physical examination
- Test of vital signs, lying and standing.
- Electrocardiogram.
- Collection of blood for chemistry and hematology.
- Urinalysis and liver function tests.
- Screen for HIV and hepatitis.
- Pregnancy test, if applicable, at the first visit and at all further visits.
Depending on the group to which they are assigned, at the second visit, patients will undergo an MRI scan or take part in a variety of computer-based tasks to measure different forms of thinking skills, emotional responses, and decision making. During the MRI scan, patients will lie still on a table that will slide into the enclosed tunnel of the MRI scanner. They will be asked to lie as still as possible. As the scanner takes pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to reduce the noise. Patients will be able to communicate with the MRI staff at all times during the scan, and they may ask to be moved out of the machine at any time. While lying in the MRI scanner, patients will be asked to perform tasks presented via a screen. These tasks will involve looking at pictures or words, and patients will be asked to make decisions about the pictures. The MRI scan will take no more than 2 hours. In regard to the computer-based tasks that participants will perform, the tasks are often games presented on a computer. Via computer, or on paper, there may be presentations of pictures that bring about an emotion.
There will be no direct treatment or therapeutic benefits to participation in this study. However, the knowledge gained may help people in the future.
Read the detailed description
The Psychopathy Checklist-Revised (Hare, 1991) allows the identification of a relatively homogeneous population of individuals who present with marked emotional dysfunction (reduced empathy, guilt and attachment to others) as well as a notable propensity for goal-directed antisocial behavior. Identification of the neuro-biological underpinnings of their emotional dysfunction is of crucial importance as the level of emotion dysfunction is an important predictor of long term prognosis.
Currently, there are two main positions regarding the neural systems that are dysfunctional in individuals with psychopathy: First, that the pathology is associated with amygdala dysfunction; Secondly, that the pathology is associated with orbital frontal cortex dysfunction. A third, more recent position, stresses the interconnections between these two systems and the role that development may play in the disorder.
The current project will determine the performance of individuals with psychopathy and comparison individuals on measures which recruit the amygdala and orbital frontal cortex. In addition, a series of functional neuro-imaging studies will directly assess neural responses in these two systems in individuals with psychopathy. Finally, a structural imaging study will examine anatomical differences between the groups. The project should provide clear data that will constrain future theorizing on the pathology implicated in this disorder.
- Conditions
- Neural Systems, Psychopathology
- Keywords
- Amygdala, Facial Affect, Instrumental Learning, Psychopathy, Emotion, Orbitofrontal Cortex, Healthy Volunteer, HV
- Medical subject headings
- Antisocial Personality Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study start27 Aug 2004
- Study completion21 Apr 2008
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 Neural SystemsStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352456
- Sponsor's protocol ID
- 040271
- Other IDs
- 04-M-0271
- Status last verified
- 21 Apr 2008
- First submitted
- 13 Jul 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Angrilli A, Mauri A, Palomba D, Flor H, Birbaumer N, Sartori G, di Paola F. Startle reflex and emotion modulation impairment after a right amygdala lesion. Brain. 1996 Dec;119 ( Pt 6):1991-2000. doi: 10.1093/brain/119.6.1991.
PubMed 9010003
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychobiological Mechanisms of Behavioral Dysregulation
- ClinicalTrials.gov ID
- NCT00352456
- Acronym / sponsor ID
- 040271
- Conditions
- Neural Systems, Psychopathology
- Keywords
- Amygdala, Facial Affect, Instrumental Learning, Psychopathy, Emotion, Orbitofrontal Cortex, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 27 Aug 2004
- Study completion
- 21 Apr 2008
- First posted
- 14 Jul 2006 (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 is directed toward a better understanding of how the brain regulates emotions and social and antisocial behavior. It will look at the use of the orbital frontal cortex and amygdala of the brain. Brain changes are involved in solving conflicts and the feelings that such conflicts produce. Conflicts may occur with other people or with general social rules. The researchers' expectations are that the findings will be useful in developing therapies that may improve people's ability to solve social conflicts and reduce antisocial behavior.
Adults ages 20 to 50 years of age with psychopathy and a second set of comparison adults, all of whom have been released from the Fairfax County Adult Detention Center, may be eligible for this study.
The neurocognitive component of the study, the one pertaining to performance of various tasks, will involve 20 adults with psychopathy and 20 comparison adults. The neuroimaging component, in which a magnetic resonance imaging (MRI) scan is used, will involve 18 adults and 18 comparison adults. Two visits by participants will be entailed. At the first visit, patients will undergo the following procedures and tests:
- Physical examination
- Test of vital signs, lying and standing.
- Electrocardiogram.
- Collection of blood for chemistry and hematology.
- Urinalysis and liver function tests.
- Screen for HIV and hepatitis.
- Pregnancy test, if applicable, at the first visit and at all further visits.
Depending on the group to which they are assigned, at the second visit, patients will undergo an MRI scan or take part in a variety of computer-based tasks to measure different forms of thinking skills, emotional responses, and decision making. During the MRI scan, patients will lie still on a table that will slide into the enclosed tunnel of the MRI scanner. They will be asked to lie as still as possible. As the scanner takes pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to reduce the noise. Patients will be able to communicate with the MRI staff at all times during the scan, and they may ask to be moved out of the machine at any time. While lying in the MRI scanner, patients will be asked to perform tasks presented via a screen. These tasks will involve looking at pictures or words, and patients will be asked to make decisions about the pictures. The MRI scan will take no more than 2 hours. In regard to the computer-based tasks that participants will perform, the tasks are often games presented on a computer. Via computer, or on paper, there may be presentations of pictures that bring about an emotion.
There will be no direct treatment or therapeutic benefits to participation in this study. However, the knowledge gained may help people in the future.
Detailed description
The Psychopathy Checklist-Revised (Hare, 1991) allows the identification of a relatively homogeneous population of individuals who present with marked emotional dysfunction (reduced empathy, guilt and attachment to others) as well as a notable propensity for goal-directed antisocial behavior. Identification of the neuro-biological underpinnings of their emotional dysfunction is of crucial importance as the level of emotion dysfunction is an important predictor of long term prognosis.
Currently, there are two main positions regarding the neural systems that are dysfunctional in individuals with psychopathy: First, that the pathology is associated with amygdala dysfunction; Secondly, that the pathology is associated with orbital frontal cortex dysfunction. A third, more recent position, stresses the interconnections between these two systems and the role that development may play in the disorder.
The current project will determine the performance of individuals with psychopathy and comparison individuals on measures which recruit the amygdala and orbital frontal cortex. In addition, a series of functional neuro-imaging studies will directly assess neural responses in these two systems in individuals with psychopathy. Finally, a structural imaging study will examine anatomical differences between the groups. The project should provide clear data that will constrain future theorizing on the pathology implicated in this disorder.
Study design
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (9 listed)
- Because factors such as psychiatric disease, or CNS disease, can influence functional brain activity, these factors are exclusionary.
- Psychiatric history: Participants will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (i.e., SCID).
- Severe acute and chronic medical illnesses. In short, any condition requiring the administration of systemic drugs will be exclusory.
- CNS disease: history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, or history of head trauma (defined as loss of consciousness greater than 3 min).
- Metal or electronic objects: Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
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 2 Jul 2017.
- Background: PubMed 9010003Angrilli A, Mauri A, Palomba D, Flor H, Birbaumer N, Sartori G, di Paola F. Startle reflex and emotion modulation impairment after a right amygdala lesion. Brain. 1996 Dec;119 ( Pt 6):1991-2000. doi: 10.1093/brain/119.6.1991.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Systems and Psychopathology, run by National Institute of Mental Health (NIMH) at 1 site 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 6 inclusion and 9 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
On the ClinicalTrials.gov record for NCT00352456, 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 2 Jul 2017.