Cortical GABA Concentrations in Insomnia
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ClinicalTrials.gov Identifier: NCT00765752 |
Recruitment Status :
Completed
First Posted : October 3, 2008
Last Update Posted : January 21, 2013
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Condition or disease |
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Insomnia Major Depression |
Study Type : | Observational |
Actual Enrollment : | 23 participants |
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 |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Group/Cohort |
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1 Primary Insomnia
Individuals with insomnia not related to another identified cause.
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3 Healthy comparison subjects
Healthy subjects with no history of insomnia
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- Cortical GABA levels as measured by proton MRS [ Time Frame: baseline ]
- Ambulatory polysomnography [ Time Frame: baseline ]

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Ages Eligible for Study: | 25 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patient Sample.
- Healthy subjects without insomnia (Group A) (n=10)
- Subjects with primary insomnia (Group B) (n=20)
- Subjects with a history of major depressive disorder and currently in partial remission but with residual insomnia (Group C) (n=20)
Inclusion Criteria for Primary Insomnia Subjects:
- Males or females between the ages of 25 and 55 years
- Clinical diagnosis of primary insomnia meeting DSM-IV criteria.
- Current insomnia ratings (current Sleep Onset Latency SOL > 30 minutes, Insomnia Severity Index (ISI) > 14, total sleep time (TST) < 6.5 hrs/night).
- No lifetime history of psychopathology other than primary insomnia.
- No sleep disorders previously identified as related to other conditions including sleep disordered breathing, restless leg syndrome, periodic limb movement disorder, chronic pain, gastro-esophageal reflux disease, sleep paralysis, nocturnal seizures, nocturia, enuresis; also narcolepsy and REM behavior disorders (assessed by clinical interview and Harvard Center and Cognition Habitual Sleep Survey).
Inclusion Criteria for Depressed Subjects:
- Males or females between the ages of 25 and 55 years
- Clinical diagnosis of major depression meeting DSM-IV criteria in partial remission (HDRS-8-17), confirmed after semi-structured interview with the SCID and HDRS.
- On monotherapy with a single SSRI medication for a period of at least 6-weeks.
- Remaining symptoms of insomnia (current Sleep Onset Latency (SOL) > 30 minutes, Insomnia Severity Index (ISI) > 14, TST < 6.5 hrs/night).
- Participation is judged clinically appropriate by treatment team.
- No sleep disorders previously identified as related to other conditions including sleep disordered breathing, restless leg syndrome, periodic limb movement disorder, chronic pain, gastro-esophageal reflux disease, sleep paralysis, nocturnal seizures, nocturia, enuresis; also narcolepsy and REM behavior disorders.
Inclusion Criteria for Healthy Control Subjects:
- Males or females between the ages of 25 and 55 years
- No lifetime history of psychopathology or insomnia (current SOL < 30mins, ISI < 4, TST > 6.5 hrs)
- At low risk for depression (e.g., no first degree relative with child onset, recurrent, psychotic or bipolar depression)
Exclusion Criteria for all Subjects:
- History of serious medical or neurological illness
- Signs of major medical or neurological illness on examination or as a result of laboratory studies
- History of psychoactive substance and/or alcohol dependence or abuse in past 6-months.
- Current use of any psychoactive medication or substance (with the exception of caffeine, as noted below, and the use of an SSRI in the depressed group), during the two weeks prior to the initial scan.
- More than the caffeine-equivalent of 3 cups of coffee per day, or any regular (i.e., more than 1x/2 weeks) use of caffeine after 7pm.
- Use of benzodiazepines or olanzapine in past 3-months.
- Pregnant or nursing
- Any implanted metal devise or metal fragments

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765752
United States, Connecticut | |
Yale Depression Research Program | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Gerard Sanacora, M.D.,Ph.D. | Yale University |
Responsible Party: | Gerard Sanacora, Professor, Yale University |
ClinicalTrials.gov Identifier: | NCT00765752 |
Other Study ID Numbers: |
0707002830 ESRC 057 |
First Posted: | October 3, 2008 Key Record Dates |
Last Update Posted: | January 21, 2013 |
Last Verified: | January 2013 |
Insomnia depression GABA magnetic resonance spectroscopy |
MRS Sleep antidepressant medication use |
Sleep Initiation and Maintenance Disorders Depression Depressive Disorder Behavioral Symptoms Mood Disorders |
Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |