The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia - Full Text View

Sponsor:	Steward St. Elizabeth's Medical Center of Boston, Inc.
Collaborator:	Sunovion
Information provided by:	Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:	NCT00826111

Purpose

The study will examine the effects of adding the sleep aid eszopiclone to Lexapro on mood and levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression, anxiety, and insomnia. The hypothesis is that levels of glutamine and glutamate will be increased in women receiving eszopiclone compared to those receiving placebo. The antidepressant effect of the medication combination will also be assessed.

Condition	Intervention	Phase
Depression Anxiety Insomnia	Drug: Eszopiclone Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Co-morbid Anxiety and Insomnia: A Proton MRS Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression

Drug Information available for: Glutamic acid Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Eszopiclone Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:

Primary Outcome Measures:

Change in glutamine concentration between baseline and one week. [ Time Frame: One week. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in glutamate and GABA concentrations from baseline to one week. [ Time Frame: One week. ] [ Designated as safety issue: No ]
Change in glutamine, glutamate, and GABA concentrations from week 8 to week 10. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Change in scores on Hamilton Depression Rating Scale (HDRS), Hamilton Anxiety Rating Scale (Ham-A), Young Mania Rating Scale (YMRS), and Insomnia Severity Index (ISI). [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	August 2007
Estimated Study Completion Date:	July 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Eszopiclone Lexapro for 10 weeks together with eszopiclone.	Drug: Eszopiclone Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone. Other Name: Lunesta
Placebo Comparator: Placebo Lexapro for 10 weeks together with placebo.	Drug: Placebo Subjects receive 10 mg of escitalopram daily for four weeks followed by 10 or 20 mg for an additional six weeks. Subjects also receive placebo for eszopiclone.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female aged 18 to 55 years and regularly menstruating.
Meets DSM-IV criteria for unipolar major depression.
Insomnia severity index score > 10.
Hamilton Anxiety scale score > 15.
Hamilton Depression scale score > 17.
Capable of providing informed consent.
Has an established residence and phone.

Exclusion Criteria:

Meets DSM-IV criteria for schizophrenia, schizoaffective disorder or other axis I or II diagnosis except co-morbid anxiety disorder and insomnia.
Actively abusing substances or alcohol; or has met DSM-IV criteria for substance dependence in the past month.
Pregnancy.
Use of benzodiazepines or other sedative-hypnotics, beta blockers, calcium channel blockers, antidepressants, antipsychotic medications, lithium or other medication which in the opinion of the investigator could alter glutamate or GABA activity in the brain.
A medical condition, which in the opinion of the investigator could possibly affect the individual's brain levels of Glu and GABA.
Participation in a research protocol that included administration of medication within the past 3 months.
Cigarette smoking.
Subject has known allergic sensitivity to any of the study to escitalopram, eszopiclone or zopiclone.
Clinically significant suicidal ideation or risk of suicide as evidenced by formulation of a plan or steps taken to act on those feelings.
History of clinically significant hepatic impairment.
Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826111

Locations

United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135

Sponsors and Collaborators

Steward St. Elizabeth's Medical Center of Boston, Inc.

Sunovion

Investigators

Principal Investigator:

Michael E Henry, MD

Steward St. Elizabeth's Medical Center of Boston, Inc.

More Information

No publications provided

Responsible Party:	Michael E. Henry, MD, Caritas St. Elizabeth's Medical Center
ClinicalTrials.gov Identifier:	NCT00826111 History of Changes
Other Study ID Numbers:	00427
Study First Received:	January 19, 2009
Last Updated:	April 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:

Magnetic Resonance Spectroscopy
Glutamate
Glutamine
GABA

Lexapro
Lunesta
Escitalopram
Eszopiclone

Additional relevant MeSH terms:

Anxiety Disorders
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Dexetimide
Citalopram
Eszopiclone
Antiparkinson Agents

Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on February 09, 2012