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

NCT00826111 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Steward St. Elizabeth's Medical Center of Boston, Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	19
Start date	2007-08
Completion	2011-07

Conditions

• Depression
• Anxiety
• Insomnia

Interventions

• Eszopiclone
• Placebo

Primary outcomes

• Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1. — baseline and 1 week
  Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.
• Change in Thalamic Glutamine From Baseline to Week 1 — baseline and 1 week
  Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.

Countries

United States