Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109642
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-04-29
Brief Title:
The Role of Norepinephrine in Emotional Processing
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigating the Role of Norepinephrine in Emotional Processing Through Alpha-2 Adrenergic Receptor Modulation
Status:
COMPLETED
Status Verified Date:
2009-06-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the role of a brain chemical called norepinephrine in thinking decision-making and emotional processing After norepinephrine is released from a brain cell it binds to another brain cells receptor Some of the receptors it binds to are called alpha-2 adrenergic receptors This study will use medicines called yohimbine and guanfacine to look at the function of norepinephrine in the brain when it binds to the alpha-2 adrenergic receptors Yohimbine increases norepinephrines function and guanfacine decreases its function
Healthy volunteers between 20 and 50 years of age who do not have heart disease high blood pressure psychiatric illness or other serious medical conditions and who are not allergic to lactose may be eligible for this study Candidates are screened with a medical and psychiatric history physical examination neuropsychological testing blood and urine tests and electrocardiogram Women are screened with a urine pregnancy test
Participants are given a pill of yohimbine guanfacine or placebo and undergo the following tests and procedures
Blood pressure and heart rate measurements Blood pressure and heart rate are measured before the medication is taken and several times after
Blood draws Blood is drawn before the medicine is taken and 90 minutes after to measure levels of norepinephrine and the hormone cortisol
Neurocognitive testing Participants do neurocognitive tasks on the computer for up to 90 minutes The tasks involve looking at pictures or words on a screen and responding according to instructions given
Magnetic resonance imaging MRI Patients may undergo neurocognitive testing MRIs This test uses a strong magnetic field and radio waves to show changes in brain activity The subject lies on a table that slides into a narrow cylinder the MRI scanner Images of the brain are obtained while the subject performs the computer tasks
Healthy volunteers between 20 and 50 years of age who do not have heart disease high blood pressure psychiatric illness or other serious medical conditions and who are not allergic to lactose may be eligible for this study Candidates are screened with a medical and psychiatric history physical examination neuropsychological testing blood and urine tests and electrocardiogram Women are screened with a urine pregnancy test
Participants are given a pill of yohimbine guanfacine or placebo and undergo the following tests and procedures
Blood pressure and heart rate measurements Blood pressure and heart rate are measured before the medication is taken and several times after
Blood draws Blood is drawn before the medicine is taken and 90 minutes after to measure levels of norepinephrine and the hormone cortisol
Neurocognitive testing Participants do neurocognitive tasks on the computer for up to 90 minutes The tasks involve looking at pictures or words on a screen and responding according to instructions given
Magnetic resonance imaging MRI Patients may undergo neurocognitive testing MRIs This test uses a strong magnetic field and radio waves to show changes in brain activity The subject lies on a table that slides into a narrow cylinder the MRI scanner Images of the brain are obtained while the subject performs the computer tasks
Detailed Description:
An understanding of the role of specific neurotransmitters in the neurocognitive functions mediating emotional processing is essential for the understanding and treatment of mood and anxiety disorders One such disorder currently regarded as untreatable is psychopathy Psychopathy has been linked with noradrenergic and amygdala disturbances However an understanding of the functional significance of the noradrenergic system in humans remains in its infancy The goal of this protocol is to use targeted noradrenergic manipulations yohimbine and guanfacine in conjunction with specific neurocognitive and neuroimaging paradigms to consider the role of norepinephrine in reward and punishment processing In particular we wish to evaluate the hypothesis that increased norepinephrine levels following the administration of yohimbine will lead to enhanced formation and processing of stimulus-reward and stimulus-punishment associations while decreased norepinephrine levels following the administration of guanfacine will reduce the formation and processing of stimulus-reward and stimulus-punishment associations In addition we aim to examine the hypothesis that increased norepinephrine levels will lead to increased neural response in the amygdala during either the formation or processing of stimulus-reinforcement associations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-M-0147 | None | None | None |