NCT05893173Completed
Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Sleep Deprivation
Pilot Study: Establishing Glutamatergic Changes as the Mechanism of Action in the Rapid Antidepressant Effects of Sleep Deprivation
Source: ClinicalTrials.gov · Last updated 27 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3 (actual)
- First submitted
- 12 May 2023
- Start date
- 19 Jun 2023
- Primary completion date
- 2 Feb 2025
- Lead sponsor
- University of Pennsylvania
- Diseases
- Depression
- NCT number
- NCT05893173
What you commit to
- Study type: Observational
- Participants enrolled: 3
- From 19 Jun 2023 to the primary completion date, 2 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Shift work, transmeridian travel or irregular sleep/wake routine in past 60 days; A sleep disorder other than insomnia, as determined by history or actigraph; History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders as assessed on the SCID; Previous electroconvulsive therapy in the past 6 months; Alcohol or drug abuse in the past year based upon the SCID or urine toxicology screen; A current smoker; Any significant medical or neurological illness that impacts brain function or impedes participation; History of head trauma with significant loss of consciousness; Metallic implants, pacemakers or tattoos, or other contraindications to MRI; Claustrophobic, or intolerant of the scanner environment; Visual or auditory impairment severe enough to compromise task performance as judged by the PI; For women, pregnancy will exclude participation.
Who the study is looking for
- Age between 18 and 85 years; Current depression as assessed on the SCID;
- Stable, normally-timed sleep-wake cycle as determined by interview, 1 week daily sleep log, and defined by:
- Habitual nocturnal sleep duration between 6h and 9h.
- Habitual morning awakening between 0600h and 0800h. Able to comprehend English, as all questionnaires are in this language Ability to provide informed consent
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.