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NCT04948944 · ClinicalTrials.gov registry record · NA
Frontal Stimulation to Modulate Threat Sensitivity in Anxious Depression
A NA study, sponsored by Laureate Institute for Brain Research.
- Completed
- Registry status
- NA
- Development phase
- 141
- Enrollment target
NCT04948944 is a NA study that has completed, run by Laureate Institute for Brain Research. The registered enrollment target is 141 participants.
The verdict
NCT04948944, a NA study, has completed, sponsored by Laureate Institute for Brain Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 141 participants
- Enrollment target
Study Summary
Over 50% of patients with major depressive disorder (MDD) do not respond to initial treatment and relapse is common. In particular, comorbid depression and anxiety disorders are associated with more treatment resistance. Thus, there is a great need for novel, more targeted treatments. Transcranial direct current stimulation (tDCS) is a novel intervention that can be used to causally target neural excitability and plasticity in brain regions/circuits implicated in regulating mood and anxiety and emerging evidence suggests that it reduces threat sensitivity. Here the investigators propose to use tDCS to target threat sensitivity as a core symptom of anxious depression to determine if the investigators can engage the neural circuits that are treatment targets. Following the administration of a single dose of anxiolytic or antidepressant treatment, early changes in emotional processing have been observed in healthy people and clinical groups. Among patients, acute cognitive effects - such as a reduction in threat sensitivity - have been shown to predict response to drug and behavioral treatments. Functional magnetic resonance imaging (fMRI) studies have confirmed hyperactive amygdala and/or hypoactive prefrontal activity in patients, indicating an imbalance of activity within this cortico-limbic circuit that sub-serves threat identification (amygdala) and top-down control (prefrontal). Specifically, treatments aiming to remediate prefrontal/ amygdala dysfunction could be a critical target in patients exhibiting these deficits. Several clinical trials have shown that administration of frontal cortex tDCS is a potentially effective treatment for MDD. However, underlying mechanisms of action are unclear. To meet this gap, the investigators propose an experimental medicine study (target identification and initial target engagement paths) where 141 volunteers with anxious MDD will be randomized to receive a single session of active or sham tDCS in a parallel design. Threat s
Interventions
- DEVICE transcranial direct current stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2023-10-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04948944
The ClinicalTrials.gov registry entry for NCT04948944 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laureate Institute for Brain Research, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which transcranial direct current stimulation is the first listed.
NCT04948944 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04948944 about?
NCT04948944 is a clinical study titled "Frontal Stimulation to Modulate Threat Sensitivity in Anxious Depression". Over 50% of patients with major depressive disorder (MDD) do not respond to initial treatment and relapse is common. In particular, comorbid depression and anxiety disorders are associated with more treatment resistance. Thus, there is a great need for novel, more targeted treatments. Transcranial d...
What is the current status of trial NCT04948944?
This trial is currently completed. It is a NA study. The enrollment target is 141 participants. The study started on 2021-04-13. Estimated completion is 2023-10-26.
What interventions are being tested in trial NCT04948944?
The interventions under investigation include: transcranial direct current stimulation (DEVICE).
Who is sponsoring clinical trial NCT04948944?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
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