NCT00004556

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 1991

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 1991

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2000

Completed
18.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 25, 2018

First QC Date

February 8, 2000

Last Update Submit

September 27, 2018

Conditions

Keywords

StimulantsAffectCognitionBrain PhysiologyBrain MetabolismCatecholaminesBrain ImagingCognitive EfficiencyDopamine Genes

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 8773823BACKGROUND
  • Baxter 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: 2784046BACKGROUND
  • Buchsbaum 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

  • Karen F Berman, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

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

Locations