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 ]

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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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Serious Adverse Events

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Other Adverse Events

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Time Frame	Adverse event data was collected at all study visits which occurred every one to two weeks.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

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

Other Adverse Events

	Eszopiclone	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	3/14	1/5
General disorders
jaw pain ^*
# participants affected / at risk	1/14 (7.14%)	0/5 (0.00%)
# events	1	0
somnolescence ^*
# participants affected / at risk	2/14 (14.29%)	0/5 (0.00%)
# events	2	0
Nervous system disorders
MRI abnormality ^*
# participants affected / at risk	0/14 (0.00%)	1/5 (20.00%)
# events	0	1

*	Events were collected by non-systematic assessment

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

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