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The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Co-morbid Anxiety and Insomnia: A Proton MRS Study

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Trial Conditions
  • Depression
  • Anxiety
  • Insomnia
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18  - 55 

Gender:
Female

Eligibility

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.

Gender: Female
Steward Physician(s)
  • Michael E Henry, MD
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • Eszopiclone
  • Placebo
Physician Researcher

Investigator Name:

  • Michael E Henry, MD

Other Information

Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Phase: Phase 4
Trial ID: NCT00826111
Volunteers:  Not Accepting Healthy Volunteers

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