Cortical GABA Concentrations in Insomnia
Disturbances in the amino acid neurotransmitter (AANt), gamma-amino butyric acid (GABA) function are hypothesized to contribute to the neurobiology of Major Depressive Disorder (MDD) and insomnia. The principal objective of this project is to use magnetic resonance spectroscopy (MRS) to provide the first in vivo characterization of cortical GABA levels in individuals with primary insomnia, and to determine whether subjects with MDD, achieving a partial response with selective serotonin reuptake inhibitor treatment but still experiencing significant residual symptoms including insomnia, have altered levels of this neurotransmitter. The investigators are also exploring the correlation between cortical AANt levels and abnormalities in sleep parameters in primary insomnia and as a residual symptom of major depression.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||The Association of Cortical GABA Concentrations in Subjects With Primary Insomnia and Depression in Partial Remission With Residual Insomnia|
- Cortical GABA levels as measured by proton MRS [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Ambulatory polysomnography [ Time Frame: baseline ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
1 Primary Insomnia
Individuals with insomnia not related to another identified cause.
3 Healthy comparison subjects
Healthy subjects with no history of insomnia
Three groups of subjects (MDD with partial remission and residual insomnia, primary insomnia, and healthy) will participate in the study. All subjects will complete a telephone screening, and if appropriate a complete face-to-face evaluation, to determine their eligibility for the study. All subjects meeting eligibility criteria for the study will complete a baseline MRS session to evaluate differences in GABA concentrations between the three groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765752
|United States, Connecticut|
|Yale Depression Research Program|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Gerard Sanacora, M.D.,Ph.D.||Yale University|