Clinical Trials Directory

Trials / Completed

CompletedNCT00931619

GABA/Glutamate Balance in Temporal Lobe Epilepsy With and Without Major Depression

Status
Completed
Phase
Study type
Observational
Enrollment
29 (actual)
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) · NIH
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

Objective: To study the relative balance of GABA (A) binding potential and glutamate utilization in subjects with localization-related epilepsy with and without depression, subjects with major depressive disorder alone, and in subjects with generalized epilepsy (expected not to have significant comorbid depression). Pilot data shows that GABA(A) binding potential and glutamate utilization are tightly coupled in healthy subjects particularly in the mesial temporal lobe. We hypothesize that subjects with epilepsy will not exhibit the same degree of coupling, and that subjects with both epilepsy and depression will exhibit an even more pronounced decoupling. Study Population: Subjects aged 18-55 with localization-related epilepsy with and without depression, subjects with generalized epilepsy, subjects with major depressive disorder (MDD) alone, and healthy controls. Design: This is a neuroimaging study, using positron emission tomography (PET) with \[11C\]flumazenil, to measure GABA(A) binding potential, and \[18F\]fluorodeoxyglucose, to measure glucose utilization (reflective of neuronal glutamate release) Magnetic resonance spectroscopy (MRS), will be used to measure GABA and glutamate in the mesial temporal cortex, and corroborate the PET results. Structural magnetic resonance images (MRI) will be obtained for MRS localization and partial volume correction of PET images. Outcome measures: The binding potential of GABA(A), the regional rate of glucose metabolism, and the levels of GABA and glutamate as measured by MRS. Patients will be stratified by seizure type and depression ratings. ...

Detailed description

Objective: To study the relative balance of GABA (A) binding potential and glutamate utilization in subjects with localization-related epilepsy with and without depression, subjects with major depressive disorder alone, and in subjects with generalized epilepsy (expected not to have significant comorbid depression). Pilot data shows that GABA(A) binding potential and glutamate utilization are tightly coupled in healthy subjects, particularly in the mesial temporal lobe. We hypothesize that subjects with epilepsy will not exhibit the same degree of coupling, and that subjects with both epilepsy and depression will exhibit an even more pronounced decoupling. Study Population: Subjects aged 18-55 with localization-related epilepsy without clinically significant depression, subjects with generalized epilepsy, and healthy controls. Design: This is a neuroimaging study, using positron emission tomography (PET) with \[11C\]flumazenil, to measure GABA(A) binding potential, and \[18F\]fluorodeoxyglucose, to measure glucose utilization (reflective of neuronal glutamate release). Magnetic resonance spectroscopy (MRS) will be used to measure GABA and glutamate in the mesial temporal cortex and corroborate the PET results. Structural magnetic resonance images (MRI) will be obtained for MRS localization and partial volume correction of PET images. Outcome measures: The binding potential of GABA(A), the regional rate of glucose metabolism, and the levels of GABA and glutamate as measured by MRS. Patients will be stratified by seizure type.

Conditions

Timeline

Start date
2009-06-29
Completion
2013-04-02
First posted
2009-07-02
Last updated
2019-12-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00931619. Inclusion in this directory is not an endorsement.