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The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
This study is currently recruiting participants.
Verified by Caritas St. Elizabeth's Medical Center of Boston, January 2009
First Received: January 19, 2009   Last Updated: January 26, 2009   History of Changes
Sponsors and Collaborators: Caritas St. Elizabeth's Medical Center of Boston
Sepracor, Inc.
Information provided by: Caritas St. Elizabeth's Medical Center of Boston
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. Moreover, it is hypothesized that changes will persist for two weeks following discontinuation of eszopiclone.


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

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
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:


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

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 Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Eszopiclone: Active Comparator
Lexapro for 10 weeks together with eszopiclone for eight weeks.
Drug: Eszopiclone
Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. For the first eight weeks, subjects also receive 3 mg eszopiclone.
Placebo: Placebo Comparator
Lexapro for 10 weeks together with placebo for eight weeks.
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 the first eight weeks.

  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

Contacts
Contact: Tara Lauriat, PhD 617-789-2404 depression@caritaschristi.org

Locations
United States, Massachusetts
Caritas St. Elizabeth's Medical Center Recruiting
Boston, Massachusetts, United States, 02135
Contact: Tara Lauriat, PhD     617-789-2404     depression@caritaschristi.org    
Sponsors and Collaborators
Caritas St. Elizabeth's Medical Center of Boston
Sepracor, Inc.
Investigators
Principal Investigator: Michael E Henry, MD Caritas St. Elizabeth's Medical Center of Boston
  More Information

No publications provided

Responsible Party: Caritas St. Elizabeth's Medical Center ( Michael E. Henry, MD )
Study ID Numbers: 00427
Study First Received: January 19, 2009
Last Updated: January 26, 2009
ClinicalTrials.gov Identifier: NCT00826111     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Caritas St. Elizabeth's Medical Center of Boston:
Magnetic Resonance Spectroscopy
Glutamate
Glutamine
GABA
Lexapro
Lunesta
Escitalopram
Eszopiclone

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Glutamine
Neurotransmitter Agents
Depression
Glutamic Acid
Psychotropic Drugs
Sleep Disorders
Dyssomnias
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Serotonin
Behavioral Symptoms
Sleep Disorders, Intrinsic
Mental Disorders
Mood Disorders
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Dyssomnias
Sleep Disorders
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Sleep Disorders, Intrinsic
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 11, 2009