Effect of Gabapentin on GABA Concentration and Emotional Processing
The Effect of Gabapentin on Prefrontal GABA Concentration and Emotional Processing in Healthy Humans
2 other identifiers
observational
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2004
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
October 14, 2004
CompletedFirst Submitted
Initial submission to the registry
October 19, 2004
CompletedFirst Posted
Study publicly available on registry
October 20, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2010
CompletedJuly 2, 2017
September 3, 2010
October 19, 2004
June 30, 2017
Conditions
Keywords
Eligibility Criteria
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
Related Publications (3)
Petroff OA. GABA and glutamate in the human brain. Neuroscientist. 2002 Dec;8(6):562-73. doi: 10.1177/1073858402238515.
PMID: 12467378BACKGROUNDMcDonagh 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: 14694031BACKGROUNDPetroff 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