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NCT03999736 · ClinicalTrials.gov registry record · Phase 1
Biomarkers of Response to Treatment With Frontal Cortex Stimulation for Anxious Depression
A Phase 1 study, sponsored by Mclean Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03999736: Clinical Trial Phase 1 study, sponsored by Mclean Hospital.
NCT03999736 is a Phase 1 study that was terminated before completion, run by Mclean Hospital. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03999736, a Phase 1 study, was terminated before completion, sponsored by Mclean Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is an add-on study to an existing multimodal neuroimaging study in MDD by investigating the acute effects of DLPFC tDCS on threat vigilance in 24-44 patients with MDD, as part of an open-label treatment intervention study. Behavioral and neural measures of threat vigilance will be taken acutely and investigated as predictors of subsequent treatment response to a four-week, fourteen-session DLPFC tDCS intervention, using a novel home-tDCS protocol. The design takes advantage of an existing rich set of candidate baseline behavioral, neural and molecular measures from the existing neuroimaging study, which could be used to predict treatment response to tDCS and thereby, aid future patient selection for clinical trials.
Primary Outcome
The Montgomery-Asberg Depression Rating Scale will be used as a measure of depressive symptoms.
Interventions
- DEVICE transcranial direct current stimulation using a Soterix mini-CT device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-02-13 |
| Est. Completion | 2021-02-09 |
| Phase | Phase 1 |
Why NCT03999736 stopped before completion
NCT03999736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which transcranial direct current stimulation using a Soterix mini-CT device is the first listed.
NCT03999736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03999736 about?
NCT03999736 is a clinical study titled "Biomarkers of Response to Treatment With Frontal Cortex Stimulation for Anxious Depression". This is an add-on study to an existing multimodal neuroimaging study in MDD by investigating the acute effects of DLPFC tDCS on threat vigilance in 24-44 patients with MDD, as part of an open-label treatment intervention study. Behavioral and neural measures of threat vigilance will be taken acutely...
What is the current status of trial NCT03999736?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-02-13. Estimated completion is 2021-02-09.
What interventions are being tested in trial NCT03999736?
The interventions under investigation include: transcranial direct current stimulation using a Soterix mini-CT device (DEVICE).
Who is sponsoring clinical trial NCT03999736?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03999736's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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