Clinical trial NCT00826111: The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Anxiety
Insomnia
Keywords: Magnetic Resonance Spectroscopy
Glutamate
Glutamine
GABA
Lexapro
Lunesta
Escitalopram
Eszopiclone
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2009-01-21
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility 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.

Primary outcomes:
measure: Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.
timeFrame: baseline and 1 week
measure: Change in Thalamic Glutamine From Baseline to Week 1
timeFrame: baseline and 1 week
Secondary outcomes:
measure: Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1
timeFrame: baseline and 1 week
measure: Change in Thalamic Glutamate From Baseline to Week 1
timeFrame: baseline and 1 week
measure: Change in Anterior Cingulate Cortex GABA From Baseline to Week 1
timeFrame: baseline and 1 week
measure: Change in Thalamic GABA From Baseline to Week 1
timeFrame: baseline and 1 week
measure: Change in Hamilton Depression Rating Scale Score From Baseline to Week 10
timeFrame: baseline and 10 weeks
measure: Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10
timeFrame: baseline and 10 weeks
measure: Change in Insomnia Severity Index Score From Baseline to Week 10
timeFrame: baseline and 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Steward St. Elizabeth's Medical Center of Boston, Inc.
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Michael E Henry, MD
role: PRINCIPAL_INVESTIGATOR
References: