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NCT01809626 · ClinicalTrials.gov registry record · Early Phase 1
Proton MRS Study of SSRI-Zolpidem Interactions
A Early Phase 1 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 14
- Enrollment target
NCT01809626 is a Early Phase 1 study that has completed, run by Mclean Hospital. The registered enrollment target is 14 participants.
The verdict
NCT01809626, a Early Phase 1 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The primary goal of this single-blind, placebo-controlled, within-subjects, double-scan, one-visit neuroimaging study is to examine the effects of the hypnotic zolpidem (Ambien®) in individuals who are maintained on selective serotonin reuptake inhibitors (SSRIs) for the treatment of major depressive disorder. Specifically, levels of the brain chemical GABA will be examined in the anterior cingulate and thalamus, two brain regions that play important roles in mediating some of the effects of depression and sleep-related drugs, respectively. Depressed individuals typically have lower levels of GABA than the healthy population, and antidepressant treatment has been shown to help normalize this neurochemical in conjunction with improved mood. Given that individuals maintained on SSRIs often are prescribed sedative/hypnotics to treat concurrent insomnia, understanding a possible neurochemical interaction between them, whether beneficial or harmful, is important for informing evidence-based treatment strategies to treat the co-morbid patient. Zolpidem's effects on GABA in participants who are maintained on SSRIs will be compared to baseline GABA levels in these individuals (i.e., following placebo administration). Two separate scanning sessions lasting approximately 45-60 min each will take place within one single study visit in order to obtain these measurements using proton magnetic resonance spectroscopy (1H MRS). This type of neuroimaging is like an MRI in that it is non-invasive, but it permits us to obtain information about chemicals in the brain. A secondary goal of this study is to compare the subjective drug effects, or how individuals feel, following the intervention. These measures will be used to determine the existence of brain-behavior relationships in order to assess the extent to which modulating GABA with zolpidem has effects on mood states in depressed participants. Collectively, this study will contribute to our understanding of how these drugs exert t
Interventions
- OTHER Placebo
- DRUG Zolpidem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01809626
The ClinicalTrials.gov registry entry for NCT01809626 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01809626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01809626 about?
NCT01809626 is a clinical study titled "Proton MRS Study of SSRI-Zolpidem Interactions". The primary goal of this single-blind, placebo-controlled, within-subjects, double-scan, one-visit neuroimaging study is to examine the effects of the hypnotic zolpidem (Ambien®) in individuals who are maintained on selective serotonin reuptake inhibitors (SSRIs) for the treatment of major depressiv...
What is the current status of trial NCT01809626?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2010-05. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01809626?
The interventions under investigation include: Placebo (OTHER), Zolpidem (DRUG).
Who is sponsoring clinical trial NCT01809626?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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