Cortical GABA Concentrations in Insomnia

Completed

• Conditions: Insomnia; Major Depression

• Registration Number: NCT00765752
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cortical GABA levels as measured by proton MRS	baseline

Secondary Outcome Measures

Name	Time	Method
Ambulatory polysomnography	baseline

Trial Locations

Locations (1)

Yale Depression Research Program; 🇺🇸 New Haven, Connecticut, United States