Effect of Gabapentin on GABA Concentration and Emotional Processing
Completed
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT00094510
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 30
- Starts
- 2004-10-14
- Expected to finish
- 2010-09-03
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
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 will also be excluded if they have: a) medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders, b) a history of drug (including benzodiazepines [BZD]) or alcohol abuse, c) smokers, d) serious suicidal ideation or behavior, e) lactose intolerance, f) caffeine dependency, g) history of allergic reaction to GBP, and h) general MRI exclusion criteria.
- 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.
- In women, there are additional exclusion criteria: i) current pregnancy (as documented by pregnancy testing at screening or at days of the challenge studies), j) current breast feeding, k) lack of reliable contraception method.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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