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Cortical GABA Concentrations in Insomnia

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Gerard Sanacora, Yale University
ClinicalTrials.gov Identifier:
NCT00765752
First received: October 1, 2008
Last updated: January 18, 2013
Last verified: January 2013
  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
Insomnia
Major Depression

Study Type: Observational
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

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Cortical GABA levels as measured by proton MRS [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ambulatory polysomnography [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: November 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 Primary Insomnia
Individuals with insomnia not related to another identified cause.
3 Healthy comparison subjects
Healthy subjects with no history of insomnia

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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765752

Locations
United States, Connecticut
Yale Depression Research Program
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Sunovion
Investigators
Principal Investigator: Gerard Sanacora, M.D.,Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Gerard Sanacora, Professor, Yale University
ClinicalTrials.gov Identifier: NCT00765752     History of Changes
Other Study ID Numbers: 0707002830, ESRC 057
Study First Received: October 1, 2008
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Insomnia
depression
GABA
magnetic resonance spectroscopy
MRS
Sleep
antidepressant medication use

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2014