Status:
COMPLETED
The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
Lead Sponsor:
Steward St. Elizabeth's Medical Center of Boston, Inc.
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Depression
Anxiety
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00826111
Start Date
August 1 2007
End Date
July 1 2011
Last Update
June 29 2012
Active Locations (1)
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1
Steward St. Elizabeth's Medical Center of Boston, Inc.
Boston, Massachusetts, United States, 02135