StressMIDASNCT01850472
Brain Mechanisms of Emotion and Motivation: A Mind-Body Study
An observational study of Stress and Anhedonia, run by Mclean Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Type of treatment
- Injection or infusion
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jan 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP)
- Written informed consent
- Both genders and all ethnic origins, age between 18 and 45
- Right-handed
- Absence of any medications for at least 3 weeks
- Absence of pregnancy as determined by completion of a negative urine pregnancy test prior to the MRI scan
- Fluent English speaker
- Absence of current drug use (cocaine, cannabinoids, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates) as assessed by a urine drug test.
Who cannot join
- Pregnant or currently breast-feeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
- History or current serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- History of seizure disorder
- Failure to meet standard fMRI safety requirements
- History of head injury
- History or current diagnosis of any DSM-IV psychiatric illnesses; Presence of a DSM-IV psychiatric illness within a first-degree relative
Show all 16Show fewer
- History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
- History of use of dopaminergic drugs (including methylphenidate)
- History or current diagnosis of dementia
- Patients with mood congruent or mood incongruent psychotic features
- History or current use of any psychiatric medication
- Current use of any drug or herbal supplement with well-characterized psychotropic effects (e.g. St. John's wort)
- Clinical or laboratory evidence of hypothyroidism
- Diabetes with poor glucose control
- Currently taking medication that affects blood flow, e.g. certain blood pressure medications
- Evidence of significant inconsistencies in self-report.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future wellbeing in follow-up interviews.
Read the detailed description
The purpose of this research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future wellbeing in follow-up interviews. Participating in this study involves up to two sessions and up to 7.5 hours. In the present observational study, each participant will be exposed to the same experimental procedure.
Visit 1 will take about 4.5 hours, from 12pm to 4:30pm. The visit will take place at the Center for Depression, Anxiety and Stress at McLean. During this visit, a clinical interviewer will conduct a diagnostic SCID interview to ensure that participants qualify to take part in this research study. Participants will then complete several tasks. These tasks include several different "game-like" situations and arithmetic riddles, all of which are simple but require participants to work hard and remain alert for an extended period of time. The goal during these games is to earn as much money as you can or to avoid losing money. Participants will do so by responding (pressing a keyboard button) quickly and accurately. These tasks are intended as assessment tools, and are not a form of therapy or intervention. In addition, we will test participants' ability to keep their hand in cold water. Participants will also be asked to provide blood (via a saline IV) and saliva samples at different times during this session, and we will also conduct urine drug and pregnancy tests. The IV will be in place for a total of around 3 hours, and is used to reduce discomfort from multiple blood draws.
Visit 2 will take place at the McLean Imaging Center at McLean Hospital. During the first part of the session, the fMRI scanner will take structural pictures of brain anatomy. Next, additional images will be obtained while participants complete several different "game-like" tasks, similar to the tasks performed in visit 1. Again, these tasks are intended as assessment tools, and are not a form of therapy or intervention. The whole fMRI session will last up to about 2.5 hours; participants will spend about 1.5 hours in the fMRI machine, and about a half-an-hour completing questionnaires and providing saliva samples. Prior to the fMRI scan, another urine sample will be obtained to check for drugs which may interfere with the experiment.
After the second study session is complete, participants will be re-contacted through the internet every four weeks for a total of six months, to complete some questionnaires. At the end of six months, participants will be asked to return to McLean to complete an in-person interview. This follow-up period is purely observational and not intended to assess health outcomes, as there is no intervention in this study.
- Keywords
- Anhedonia, Depression, Stress, Cortisol, Inflammatory cytokines, Learning, Magnetic resonance imaging (MRI)
- Medical subject headings
- Anhedonia, Depression
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 |
|---|---|---|
| Healthy controls | Individuals with no psychiatric diagnosis as determined by structured clinical interview for DSM-IV (SCID) at time of enrollment. There is no intervention administered in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Activity during Instrumental Learning Task
Functional magnetic resonance imaging (fMRI) data are acquired while participants perform the instrumental learning task. fMRI data allows us to measure aspects of brain activity.
Measured: 2 hour long scan during session 2
Change in Behavioral Performance in Instrumental Learning Task
The instrumental learning task is designed to measure participant learning from reward and punishment. It will be administered twice during session 1 to calculate changes in reward and punishment sensitivity.
Measured: Administered during session 1 twice for a total of 10 minutes
Behavioral performance in Effort-Expenditure for Rewards Task
The instrumental learning task is designed to measure reward sensitivity.
Measured: 15 minute task during session 2
Change in Questionnaire Data
At all sessions participants will fill out self-report questionnaires regarding aspects of mood and affect, demographics, caffeine and alcohol consumption, etc. Questionnaires will be completed on paper forms or through the electronic data entry system "RedCap Survey", a HIPPAA compliant secure and encrypted online database. We will use these data to assess changes in participant behavior.
Measured: Administered continuously during the two study sessions (total 7 hours); follow-up questionnaires sent out every 2 weeks for a total of 4 months
Change in Behavioral Performance in Probabilistic Reward Task
The probabilistic reward task is designed to measure sensitivity to reward and reward learning. It will be administered three times during session 1 to calculate changes in reward and punishment sensitivity.
Measured: Given three times during session 1 for a total of 35 minutes
Life Events and Difficulties (LEDS) interview
The LEDS interview is designed to assess life experiences and emotional responses.
Measured: 6 months after completion of session 2
Change in salivary hormone levels
A total of ten saliva samples will be taken before, during and after the tasks in sessions 1 and 2 to monitor changes in hormone levels.
Measured: During sessions 1 and 2 (a total of 7 hours) saliva samples will be repeatedly gathered
Salivary genetic analysis
One Saliva sample will be gathered from each participant to analyze genetic markers.
Measured: 5 minute saliva sample gathered at the beginning of session 1
Change in inflammatory cytokine levels in blood plasma
Blood will be drawn from participants before, during and after the various tasks in session 1. Changes in inflammatory cytokine levels in blood plasma will be measured to gauge physiological responses to tasks.
Measured: 3 blood samples, each taking 10 minutes, gathered over the course of session 1 for a total of 30 minutes
Behavioral Performance in Instrumental Learning Task
The instrumental learning task is designed to measure participant learning from reward and punishment.
Measured: Administered in session 2 during two hour long scan
Secondary outcomes (1)
Change in Behavioral performance in Reaction Time task
The Reaction Time task is designed to control for individual differences in reaction time and fatigue during the session.
Measured: Given 3 times during session 1 for a total of 9 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- 88 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 Pizzagalli, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850472
- Sponsor's protocol ID
- 2012P001786
- Other IDs
- 5R01MH068376
- Acronym
- MIDAS
- Status last verified
- May 2018
- First submitted
- 2 May 2013
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Emotion and Motivation: A Mind-Body Study
- ClinicalTrials.gov ID
- NCT01850472
- Acronym / sponsor ID
- MIDAS / 2012P001786
- Keywords
- Anhedonia, Depression, Stress, Cortisol, Inflammatory cytokines, Learning, Magnetic resonance imaging (MRI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 May 2013 (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 research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future wellbeing in follow-up interviews.
Detailed description
The purpose of this research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future wellbeing in follow-up interviews. Participating in this study involves up to two sessions and up to 7.5 hours. In the present observational study, each participant will be exposed to the same experimental procedure.
Visit 1 will take about 4.5 hours, from 12pm to 4:30pm. The visit will take place at the Center for Depression, Anxiety and Stress at McLean. During this visit, a clinical interviewer will conduct a diagnostic SCID interview to ensure that participants qualify to take part in this research study. Participants will then complete several tasks. These tasks include several different "game-like" situations and arithmetic riddles, all of which are simple but require participants to work hard and remain alert for an extended period of time. The goal during these games is to earn as much money as you can or to avoid losing money. Participants will do so by responding (pressing a keyboard button) quickly and accurately. These tasks are intended as assessment tools, and are not a form of therapy or intervention. In addition, we will test participants' ability to keep their hand in cold water. Participants will also be asked to provide blood (via a saline IV) and saliva samples at different times during this session, and we will also conduct urine drug and pregnancy tests. The IV will be in place for a total of around 3 hours, and is used to reduce discomfort from multiple blood draws.
Visit 2 will take place at the McLean Imaging Center at McLean Hospital. During the first part of the session, the fMRI scanner will take structural pictures of brain anatomy. Next, additional images will be obtained while participants complete several different "game-like" tasks, similar to the tasks performed in visit 1. Again, these tasks are intended as assessment tools, and are not a form of therapy or intervention. The whole fMRI session will last up to about 2.5 hours; participants will spend about 1.5 hours in the fMRI machine, and about a half-an-hour completing questionnaires and providing saliva samples. Prior to the fMRI scan, another urine sample will be obtained to check for drugs which may interfere with the experiment.
After the second study session is complete, participants will be re-contacted through the internet every four weeks for a total of six months, to complete some questionnaires. At the end of six months, participants will be asked to return to McLean to complete an in-person interview. This follow-up period is purely observational and not intended to assess health outcomes, as there is no intervention in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –Individuals with no psychiatric diagnosis as determined by structured clinical interview for DSM-IV (SCID) at time of enrollment. There is no intervention administered in this study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (8 listed)
- Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP)
- Written informed consent
- Both genders and all ethnic origins, age between 18 and 45
- Right-handed
- Absence of any medications for at least 3 weeks
Key exclusion criteria (16 listed)
- Pregnant or currently breast-feeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
- History or current serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- History of seizure disorder
- Failure to meet standard fMRI safety requirements
- History of head injury
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
Brain Activity during Instrumental Learning Task
Time frame: 2 hour long scan during session 2
Functional magnetic resonance imaging (fMRI) data are acquired while participants perform the instrumental learning task. fMRI data allows us to measure aspects of brain activity.
Change in Behavioral Performance in Instrumental Learning Task
Time frame: Administered during session 1 twice for a total of 10 minutes
The instrumental learning task is designed to measure participant learning from reward and punishment. It will be administered twice during session 1 to calculate changes in reward and punishment sensitivity.
Behavioral performance in Effort-Expenditure for Rewards Task
Time frame: 15 minute task during session 2
The instrumental learning task is designed to measure reward sensitivity.
Change in Questionnaire Data
Time frame: Administered continuously during the two study sessions (total 7 hours); follow-up questionnaires sent out every 2 weeks for a total of 4 months
At all sessions participants will fill out self-report questionnaires regarding aspects of mood and affect, demographics, caffeine and alcohol consumption, etc. Questionnaires will be completed on paper forms or through the electronic data entry system "RedCap Survey", a HIPPAA compliant secure and encrypted online database. We will use these data to assess changes in participant behavior.
Change in Behavioral Performance in Probabilistic Reward Task
Time frame: Given three times during session 1 for a total of 35 minutes
The probabilistic reward task is designed to measure sensitivity to reward and reward learning. It will be administered three times during session 1 to calculate changes in reward and punishment sensitivity.
Life Events and Difficulties (LEDS) interview
Time frame: 6 months after completion of session 2
The LEDS interview is designed to assess life experiences and emotional responses.
Change in salivary hormone levels
Time frame: During sessions 1 and 2 (a total of 7 hours) saliva samples will be repeatedly gathered
A total of ten saliva samples will be taken before, during and after the tasks in sessions 1 and 2 to monitor changes in hormone levels.
Salivary genetic analysis
Time frame: 5 minute saliva sample gathered at the beginning of session 1
One Saliva sample will be gathered from each participant to analyze genetic markers.
Change in inflammatory cytokine levels in blood plasma
Time frame: 3 blood samples, each taking 10 minutes, gathered over the course of session 1 for a total of 30 minutes
Blood will be drawn from participants before, during and after the various tasks in session 1. Changes in inflammatory cytokine levels in blood plasma will be measured to gauge physiological responses to tasks.
Behavioral Performance in Instrumental Learning Task
Time frame: Administered in session 2 during two hour long scan
The instrumental learning task is designed to measure participant learning from reward and punishment.
1 secondary outcome
Change in Behavioral performance in Reaction Time task
Time frame: Given 3 times during session 1 for a total of 9 minutes
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 22 May 2018.
- Individual participant dataSharing planned: No
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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 Pizzagalli, PhD principal investigator
Mclean Hospital
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 Stress and Anhedonia, run by Mclean Hospital 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 8 inclusion and 16 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 22 May 2018. 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.
What does the primary outcome measure?
Brain Activity during Instrumental Learning Task (time frame: 2 hour long scan during session 2). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 22 May 2018.