The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia

Completed · Phase 4 · Has a placebo group

Conditions studied: Depression, Anxiety, Insomnia

In brief

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.

Key facts

Study ID

NCT00826111

Run by

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

People needed

19

Starts

2007-08-01

Expected to finish

2011-07-01

Last updated by the study team

2012-06-29

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Steward St. Elizabeth's Medical Center of Boston, Inc. — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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