The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
Information source: Caritas St. Elizabeth's Medical Center of Boston
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Anxiety; Insomnia
Intervention: Eszopiclone (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Caritas St. Elizabeth's Medical Center of Boston Official(s) and/or principal investigator(s):
Michael E Henry, MD, Principal Investigator, Affiliation: Caritas St. Elizabeth's Medical Center of Boston
Overall contact:
Tara Lauriat, PhD, Phone: 617-789-2404, Email: depression@caritaschristi.org
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Change in glutamine concentration between baseline and one week.
Secondary outcome: Change in glutamate and GABA concentrations from baseline to one week.Change in glutamine, glutamate, and GABA concentrations from week 8 to week 10. Change in scores on Hamilton Depression Rating Scale (HDRS), Hamilton Anxiety Rating Scale (Ham-A), Young Mania Rating Scale (YMRS), and Insomnia Severity Index (ISI).
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Tara Lauriat, PhD, Phone: 617-789-2404, Email: depression@caritaschristi.org
Caritas St. Elizabeth's Medical Center, Boston, Massachusetts 02135, United States; Recruiting
Tara Lauriat, PhD, Phone: 617-789-2404, Email: depression@caritaschristi.org
Additional Information
Starting date: August 2007
Last updated: January 26, 2009
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