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Sponsors and Collaborators: |
Caritas St. Elizabeth's Medical Center of Boston Sepracor, Inc. |
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Information provided by: | Caritas St. Elizabeth's Medical Center of Boston |
ClinicalTrials.gov Identifier: | NCT00826111 |
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 |
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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 |
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 |
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Eszopiclone: Active Comparator
Lexapro for 10 weeks together with eszopiclone for eight weeks.
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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.
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Placebo: Placebo Comparator
Lexapro for 10 weeks together with placebo for eight weeks.
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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.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tara Lauriat, PhD | 617-789-2404 | depression@caritaschristi.org |
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 |
Principal Investigator: | Michael E Henry, MD | Caritas St. Elizabeth's Medical Center of Boston |
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 |
Magnetic Resonance Spectroscopy Glutamate Glutamine GABA |
Lexapro Lunesta Escitalopram Eszopiclone |
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 |
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 |