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NCT00826111 · ClinicalTrials.gov registry record · Phase 4
The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
A Phase 4 study, sponsored by Steward St. Elizabeth's Medical Center of Boston.
- Completed
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT00826111: Completed Phase 4 study, sponsored by Steward St. Elizabeth's Medical Center of Boston.
NCT00826111 is a Phase 4 study that has completed, run by Steward St. Elizabeth's Medical Center of Boston. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00826111, a Phase 4 study, has completed, sponsored by Steward St. Elizabeth's Medical Center of Boston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
What the finished NCT00826111 record still lists
NCT00826111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00826111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00826111 about?
NCT00826111 is a clinical study titled "The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia". 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 mediati...
What is the current status of trial NCT00826111?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2007-08. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00826111?
The interventions under investigation include: Placebo (DRUG), Eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00826111?
This trial is sponsored by Steward St. Elizabeth's Medical Center of Boston, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00826111's enrollment target sits among peer trials
19 1834th of 2000 higher than 159 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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