500 Boylston Street, Boston, MA 02116 617-419-4700
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The study examined 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. Specifically, the objective was to determine the role of glutamate,
glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis
was 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
and its effect on sleep status was also assessed.
Ages:18 - 55
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.
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Phase: Phase 4
Trial ID: NCT00826111
Not Accepting Healthy Volunteers