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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
Sepracor, Inc. |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00765752 |
Purpose
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.
| Condition |
|---|
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Insomnia Major Depression |
| Study Type: | Observational |
| Study Design: | Case Control, Cross-Sectional |
| Official Title: | The Association of Cortical GABA Concentrations in Subjects With Primary Insomnia and Depression in Partial Remission With Residual Insomnia |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1 Primary Insomnia
Individuals with insomnia not related to another identified cause.
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2 Remitted depression with residual insomnia
Individuals with a history of major depression treated successfully with a standard antidepressant medication who continue to have insomnia
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3 Healthy comparison subjects
Healthy subjects with no history of insomnia
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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.
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
community sample
Patient Sample.
Inclusion Criteria for Primary Insomnia Subjects:
Inclusion Criteria for Depressed Subjects:
Inclusion Criteria for Healthy Control Subjects:
Exclusion Criteria for all Subjects:
Contacts and Locations| Contact: Donna K Fasula, APRN | 203-764-9131 | madonna.fasula@yale.edu |
| Contact: KristaJoy Altland, BS | 203-764-9141 | kristajoy.altland@yale.edu |
| United States, Connecticut | |
| Yale Depression Research Program | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Donna K Fasula, APRN 203-764-9131 madonna.fasula@yale.edu | |
| Principal Investigator: | Gerard Sanacora, M.D.,Ph.D. | Yale University |
More Information
| Responsible Party: | Yale University ( Gerard Sanacora M.D., Ph.D. ) |
| Study ID Numbers: | 0707002830, ESRC 057 |
| Study First Received: | October 1, 2008 |
| Last Updated: | October 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00765752 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Insomnia depression GABA magnetic resonance spectroscopy |
MRS Sleep antidepressant medication use |
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Sleep Initiation and Maintenance Disorders Depression Mental Disorders Nervous System Diseases Mood Disorders Sleep Disorders |
Dyssomnias Depressive Disorder, Major Depressive Disorder Sleep Disorders, Intrinsic Behavioral Symptoms |