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The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT00826111
First received: January 19, 2009
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
Results First Received: October 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Anxiety
Insomnia
Interventions: Drug: Eszopiclone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from September 2008 until October 2010. Participants were recruited by advertising in the community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled participants were excluded before assignment to groups if they had another co-morbid psychiatric diagnosis, a medical condition that could affect glutamate or GABA levels, a clinical presentation that was not consistent with a diagnosis of major depressive disorder, or rating scale scores below the minimum for inclusion.

Reporting Groups
  Description
Eszopiclone Lexapro for 10 weeks together with eszopiclone.
Placebo Escitalopram with placebo

Participant Flow:   Overall Study
    Eszopiclone     Placebo  
STARTED     14     5  
COMPLETED     7     3  
NOT COMPLETED     7     2  
Lost to Follow-up                 0                 1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 5                 0  
Physician Decision                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Eszopiclone Lexapro for 10 weeks together with eszopiclone.
Placebo Escitalopram with placebo
Total Total of all reporting groups

Baseline Measures
    Eszopiclone     Placebo     Total  
Number of Participants  
[units: participants]
 		  14     5     19  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     14     5     19  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  29.8  ± 7.5     25.4  ± 5.0     28.6  ± 7.1  
Gender  
[units: participants]
 		     
Female     14     5     19  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     14     5     19  



  Outcome Measures
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1.  Primary:   Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.   [ Time Frame: baseline and 1 week ]
  Show Outcome Measure 1

2.  Primary:   Change in Thalamic Glutamine From Baseline to Week 1   [ Time Frame: baseline and 1 week ]
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3.  Secondary:   Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1   [ Time Frame: baseline and 1 week ]
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4.  Secondary:   Change in Thalamic Glutamate From Baseline to Week 1   [ Time Frame: baseline and 1 week ]
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5.  Secondary:   Change in Anterior Cingulate Cortex GABA From Baseline to Week 1   [ Time Frame: baseline and 1 week ]
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6.  Secondary:   Change in Thalamic GABA From Baseline to Week 1   [ Time Frame: baseline and 1 week ]
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7.  Secondary:   Change in Hamilton Depression Rating Scale Score From Baseline to Week 10   [ Time Frame: baseline and 10 weeks ]
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8.  Secondary:   Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10   [ Time Frame: baseline and 10 weeks ]
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9.  Secondary:   Change in Insomnia Severity Index Score From Baseline to Week 10   [ Time Frame: baseline and 10 weeks ]
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Measure Type Secondary
Measure Title Change in Insomnia Severity Index Score From Baseline to Week 10
Measure Description The Insomnia Severity Index is a 7 item scale that assesses difficulty sleeping and effect on quality of life with item scores from 0-4. The total score range is 0 to 28 with higher scores indicating higher levels of impairment and distress.
Time Frame baseline and 10 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Eszopiclone Lexapro for 10 weeks together with eszopiclone.
Placebo Escitalopram with placebo

Measured Values
    Eszopiclone     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  10     4  
Change in Insomnia Severity Index Score From Baseline to Week 10  
[units: scores on a scale]
Mean ± Standard Deviation 		  -11.2  ± 8.30     -9.5  ± 5.45  


Statistical Analysis 1 for Change in Insomnia Severity Index Score From Baseline to Week 10
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.66
Mean Difference (Final Values) [4] -1.7
Standard Error of the mean ± 3.78
95% Confidence Interval ( -10.31 to 6.91 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Withdrawal of support by the funding sponsor due to other priorities resulted in a very small sample size with a small placebo group. Participant withdrawal and unusable data explains discrepancies in subject numbers in some analyses.  


Results Point of Contact:  
Name/Title: Tara Lauriat, Ph.D.
Organization: Steward St. Elizabeth's Medical Center of Boston, Inc.
phone: 617-789-2404
e-mail: tara.lauriat@steward.org


No publications provided


Responsible Party: Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT00826111     History of Changes
Other Study ID Numbers: 00427
Study First Received: January 19, 2009
Results First Received: October 27, 2011
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board