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NCT05893173 · ClinicalTrials.gov registry record

Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Sleep Deprivation

A clinical trial, sponsored by University of Pennsylvania.

Completed
Registry status
3
Enrollment target

NCT05893173: Completed study, sponsored by University of Pennsylvania.

NCT05893173 is a clinical trial that has completed, run by University of Pennsylvania. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05893173 has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
3 participants
Enrollment target

Study Summary

In the treatment of Major Depressive Disorder (MDD), total sleep deprivation can produce rapid but short-lasting improvements in mood. In order to develop a new generation of treatments with rapid and sustained efficacy, a better understanding of the mechanism of action is urgently needed. One candidate mechanism is the modulation of synaptic strength mediated by glutamatergic activity as sleep deprivation has been suggested to increase synaptic strength. Although determining how sleep deprivation impacts the glutamatergic system is essential to isolating its mechanism of action, the invasive nature of most assessment methods has limited our ability to do so in humans. The proposed research aims to determine if changes in glutamatergic activity, reflecting the modulation of synaptic strength, underlie the antidepressant effects of sleep deprivation. In this project, the investigators will utilize a novel measure of glutamate imaging, GluCEST, to assess changes in glutamatergic activity, in addition to using a proxy measure, waking EEG theta activity, to assess synaptic strength following total sleep deprivation. Ten individuals (aged 18-85) with a DSM-V diagnosis of MDD will undergo baseline GluCEST imaging and waking EEG prior to and following approximately 30 hours of total sleep deprivation. Both clinician-administered and subjective mood measures will be collected. It is predicted that sleep deprivation will improve mood and increase glutamatergic activity and synaptic strength. Results from this project have the potential to identify the modifiable mechanisms by which rapid antidepressants work which could ultimately stimulate the development of novel interventions that work through the modulation of glutamatergic activity.

Primary Outcome

relative change in glutamate concentration (% baseline)

Interventions

  • BEHAVIORAL Sleep Deprivation

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2023-06-19
Est. Completion 2025-02-02
University of Pennsylvania

1,423 total trials

What the finished NCT05893173 record still lists

NCT05893173 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Sleep Deprivation is the first listed.

NCT05893173 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05893173 about?

NCT05893173 is a clinical study titled "Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Sleep Deprivation". In the treatment of Major Depressive Disorder (MDD), total sleep deprivation can produce rapid but short-lasting improvements in mood. In order to develop a new generation of treatments with rapid and sustained efficacy, a better understanding of the mechanism of action is urgently needed. One candi...

What is the current status of trial NCT05893173?

This trial is currently completed. The enrollment target is 3 participants. The study started on 2023-06-19. Estimated completion is 2025-02-02.

What interventions are being tested in trial NCT05893173?

The interventions under investigation include: Sleep Deprivation (BEHAVIORAL).

Who is sponsoring clinical trial NCT05893173?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05893173, the US trial registry maintained by the National Library of Medicine. NCT05893173 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.