Mental Disorders Clinical Trial
Official title:
Investigating the Role of Norepinephrine in Emotional Processing Through Alpha-2 Adrenergic Receptor Modulation
Verified date | June 8, 2009 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 cell's 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 norepinephrine's 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.
Status | Completed |
Enrollment | 216 |
Est. completion date | March 15, 2009 |
Est. primary completion date | March 15, 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility |
- INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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 (SCID). All participants will be free of any current or past major affective disorder, psychotic disorder, substance dependence, anorexia, somatoform disorder, or anxiety disorders with the exception of specific phobias. - Severe acute and chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy). - CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness greater than 3 minutes. - Currently on regular medication that would interfere with study results. This includes alpha and beta adrenergic medications, other anti-hypertensive medications, glucocorticoid and mineralocorticoid medications, and medications causing sedation or stimulation. For example, current use of tylenol or ibuprofen is permitted, while current use of benadryl or methylphenidate is not. Use of oral contraceptive pills is permitted. - Currently breast feeding or pregnant (as documented by pregnancy testing at screening or at days of the challenge studies). Additional exclusion criteria for fMRI studies: - 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. - Body weight - to reduce the likelihood of significant orthostasis from guanfacine, participants must weigh 60kg or greater. Those weighing less than 60 kg will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Adolphs R. Neural systems for recognizing emotion. Curr Opin Neurobiol. 2002 Apr;12(2):169-77. Review. — View Citation
Arnsten AF. Adrenergic targets for the treatment of cognitive deficits in schizophrenia. Psychopharmacology (Berl). 2004 Jun;174(1):25-31. Epub 2003 Dec 19. Review. — View Citation
Aron AR, Fletcher PC, Bullmore ET, Sahakian BJ, Robbins TW. Stop-signal inhibition disrupted by damage to right inferior frontal gyrus in humans. Nat Neurosci. 2003 Feb;6(2):115-6. Erratum in: Nat Neurosci. 2003 Dec;6(12):1329. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Recruiting |
NCT06012149 -
Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry
|
N/A | |
Recruiting |
NCT03222375 -
SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism
|
N/A | |
Active, not recruiting |
NCT02836080 -
Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)
|
N/A | |
Active, not recruiting |
NCT02907658 -
Efficacy of Internet Use Disorder Prevention
|
N/A | |
Completed |
NCT02710344 -
Using Telehealth to Improve Psychiatric Symptom Management
|
N/A | |
Enrolling by invitation |
NCT02487888 -
A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care
|
N/A | |
Recruiting |
NCT02292056 -
Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
|
N/A | |
Active, not recruiting |
NCT02761733 -
The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers
|
N/A | |
Completed |
NCT01947283 -
Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
|
N/A | |
Completed |
NCT01633138 -
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
|
N/A | |
Completed |
NCT01690013 -
Life Quality and Health in Patients With Klinefelter Syndrome
|
N/A | |
Completed |
NCT01656707 -
Adaptive Treatment for Adolescent Cannabis Use Disorders
|
N/A | |
Completed |
NCT01415323 -
Agitation in the Acute Psychiatric Department
|
||
Completed |
NCT01701765 -
Outcomes and Discharge of Long-stay Psychiatric Patients
|
N/A | |
Completed |
NCT00375167 -
Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery
|
N/A | |
Terminated |
NCT00757497 -
Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia
|
Phase 1 | |
Terminated |
NCT03527550 -
Cognitive Control Training for Urgency in a Naturalistic Clinical Setting
|
N/A | |
Withdrawn |
NCT03518996 -
Non-Invasive Brain Stimulation and Delirium
|
N/A |