Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cortical GABA Concentrations in Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765752
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : January 21, 2013
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Gerard Sanacora, Yale University

Tracking Information
First Submitted Date October 1, 2008
First Posted Date October 3, 2008
Last Update Posted Date January 21, 2013
Study Start Date November 2007
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2008)
Cortical GABA levels as measured by proton MRS [ Time Frame: baseline ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 2, 2008)
Ambulatory polysomnography [ Time Frame: baseline ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cortical GABA Concentrations in Insomnia
Official Title The Association of Cortical GABA Concentrations in Subjects With Primary Insomnia and Depression in Partial Remission With Residual Insomnia
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample
Condition
  • Insomnia
  • Major Depression
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 18, 2013)
23
Original Estimated Enrollment
 (submitted: October 2, 2008)
50
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00765752
Other Study ID Numbers 0707002830
ESRC 057
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gerard Sanacora, Yale University
Study Sponsor Yale University
Collaborators Sunovion
Investigators
Principal Investigator: Gerard Sanacora, M.D.,Ph.D. Yale University
PRS Account Yale University
Verification Date January 2013