CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
Eszopiclone +1 moredrug
Likely dose
Eszopiclone 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00826111
NCT00826111Phase 4Completed
CompareCT.gov

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

Steward St. Elizabeth's Medical Center of Boston, Inc.·interventional·Posted Jan 21, 2009·Updated Jun 29, 2012

In Brief

A Phase 4 clinical trial evaluating Eszopiclone and Placebo for Depression and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Anxiety, Insomnia
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc.

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 21, 2009
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.4 years ago

Interventions

Eszopiclonedrug

Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone.

Placebodrug

Subjects receive 10 mg of escitalopram daily for four weeks followed by 10 or 20 mg for an additional six weeks. Subjects also receive placebo for eszopiclone.