The Effects of Dextroamphetamine on Brain Function
Mechanisms of Individual Variation of Dextroamphetamine Effects in Normal Human Subjects
2 other identifiers
observational
108
1 country
1
Brief Summary
The purpose of this study is to determine the effects of the drug dextroamphetamine on the brain function and mood of healthy volunteers. Monoaminergic drugs are substances that affect the nervous system; these drugs can raise, hamper, or have no effect on brain function when given to healthy individuals. Different responses to a drug may be the result of genetic variations. This study will examine the effects of the monoaminergic drug dextroamphetamine on thought and sensorimotor processes while participants perform a variety of tasks. Participants in this study will undergo a medical history, physical examination, blood tests, and an electrocardiogram (EKG). Women of reproductive potential will undergo a pregnancy test. Participants will be given either dextroamphetamine or placebo (an inactive solution) on two occasions separated by at least 3 to 7 days. Participants will then perform neuropsychological tests that will measure attention, problem solving, memory, and ability to complete simple motor tasks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 1991
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 1991
CompletedFirst Submitted
Initial submission to the registry
February 8, 2000
CompletedFirst Posted
Study publicly available on registry
February 9, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2018
CompletedSeptember 28, 2018
September 25, 2018
February 8, 2000
September 27, 2018
Conditions
Keywords
Eligibility Criteria
You may not qualify if:
- Prior participation as a normal volunteer under NIH protocol # 95-M-0150.
- No Axis I or Axis II diagnosis.
- Age range: 18-45 years.
- Subjects with an Axis I or II disorder will be excluded.
- Subjects with a history of cardiovascular disease and other medical illnesses, substance abuse or recreational drug use, and hypertension will be excluded. An electrocardiogram, blood pressure and pulse rate will be checked on all subjects prior to participation in the study.
- Pregnant women. Women of childbearing potential will undergo a urine pregnancy test the day of the study and screened by history for the possibility of pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Baxter DN. The mortality experience of individuals on the Salford Psychiatric Case Register. I. All-cause mortality. Br J Psychiatry. 1996 Jun;168(6):772-9. doi: 10.1192/bjp.168.6.772.
PMID: 8773823BACKGROUNDBaxter LR Jr, Schwartz JM, Phelps ME, Mazziotta JC, Guze BH, Selin CE, Gerner RH, Sumida RM. Reduction of prefrontal cortex glucose metabolism common to three types of depression. Arch Gen Psychiatry. 1989 Mar;46(3):243-50. doi: 10.1001/archpsyc.1989.01810030049007.
PMID: 2784046BACKGROUNDBuchsbaum MS, Wu J, DeLisi LE, Holcomb H, Kessler R, Johnson J, King AC, Hazlett E, Langston K, Post RM. Frontal cortex and basal ganglia metabolic rates assessed by positron emission tomography with [18F]2-deoxyglucose in affective illness. J Affect Disord. 1986 Mar-Apr;10(2):137-52. doi: 10.1016/0165-0327(86)90036-4.
PMID: 2941470BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Karen F Berman, M.D.
National Institute of Mental Health (NIMH)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2000
First Posted
February 9, 2000
Study Start
September 30, 1991
Study Completion
September 25, 2018
Last Updated
September 28, 2018
Record last verified: 2018-09-25