NCT00094510

Brief Summary

This study will use magnetic resonance spectroscopy (MRS) and the drug gabapentin to examine the role of the brain chemical gamma-amino-butyric acid (GABA) in regulating emotions in healthy people. Gabapentin, which is used to treat epilepsy, increases GABA concentrations in the brain. MRS, similar to magnetic resonance imaging (MRI), is a diagnostic test that uses a magnetic field and radio waves to produce images of the brain. Non-smoking, healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, psychiatric evaluation, blood and urine tests, and an electrocardiogram (EKG). At three separate clinic visits, participants are given either gabapentin or a placebo (an inactive look-alike capsule). They take placebo at one visit, 600 mg of gabapentin at another visit, and 1200 mg of gabapentin at another visit. One hour after taking the capsules, the amount of GABA in the brain is measured by MRS. For this procedure, the subject lies on a table that moves into the MRI scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 45 to 60 minutes, during which the patient is asked to lie still for up to a few minutes at a time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2004

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

October 14, 2004

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2004

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2010

Completed
Last Updated

July 2, 2017

Status Verified

September 3, 2010

First QC Date

October 19, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

Prefrontal GABAStressEmotion RecognitionDifferential RewardGabapentinGABAPrefrontal CortexEmotional ProcessingHealthy HumansHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Family history of mental illness (mood and anxiety disorders, schizophrenia and other psychotic disorders, substance abuse disorders) will be obtained in all 1st degree relatives using the Family Interview of Genetic Studies.
  • Healthy Control Samples: 34 healthy subjects (ages 18-60) without a known personal or family history of psychiatric disorders in first-degree relatives will be selected.

You may not qualify if:

  • Pregnant females will be excluded due to the potential risk of magnetic field exposure during pregnancy.
  • If any subject appears incapable of providing informed consent, they will be excluded from the study.
  • Subjects must not have taken centrally active medication for at least 3 weeks prior to the study.
  • Subjects must exhibit no or only moderate alcohol use.
  • Subjects beyond age 60 are excluded because of slower elimination of GBP in older adults, and the age-related increase in brain structural abnormalities.

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)

  • Petroff OA. GABA and glutamate in the human brain. Neuroscientist. 2002 Dec;8(6):562-73. doi: 10.1177/1073858402238515.

    PMID: 12467378BACKGROUND
  • McDonagh J, Stephen LJ, Dolan FM, Parks S, Dutton GN, Kelly K, Keating D, Sills GJ, Brodie MJ. Peripheral retinal dysfunction in patients taking vigabatrin. Neurology. 2003 Dec 23;61(12):1690-4. doi: 10.1212/01.wnl.0000098938.80082.25.

    PMID: 14694031BACKGROUND
  • Petroff OA, Hyder F, Rothman DL, Mattson RH. Effects of gabapentin on brain GABA, homocarnosine, and pyrrolidinone in epilepsy patients. Epilepsia. 2000 Jun;41(6):675-80. doi: 10.1111/j.1528-1157.2000.tb00227.x.

    PMID: 10840398BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 19, 2004

First Posted

October 20, 2004

Study Start

October 14, 2004

Study Completion

September 3, 2010

Last Updated

July 2, 2017

Record last verified: 2010-09-03

Locations