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NCT02141776 · ClinicalTrials.gov registry record · Phase 4
Comparison of Anodal Transcranial Direct Current Stimulation (t-DCS) and Sham Stimulation in Patients With Treatment-resistant Depression
A Phase 4 study of Major Depressive Disorder, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT02141776 is a Phase 4 study of Major Depressive Disorder that has completed, run by University of Florida. The registered enrollment target is 3 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02141776, a Phase 4 study of Major Depressive Disorder, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
Major depressive disorder (MDD) is a significant public health problem. Existing treatment modalities are not always sufficient to alleviate this disorder. Treatment refractoriness is a common clinical problem. Transcranial direct current stimulation (t-DCS), a non-invasive brain stimulation technique, has been shown to be effective in alleviating depressive symptoms in preliminary studies. There is need to explore the role of t-DCS in Treatment-resistant depression (TRD). Therefore, the investigators aim to undertake this exploratory study. Aim: Compare the role of left prefrontal cortex anodal t-DCS daily stimulation of 4 weeks (20 week days) with sham stimulation in alleviating depressive symptoms in patients with TRD. Methodology: Patients who seek treatment in our treatment resistant depression clinic and who have failed to respond to treatment with two antidepressant medications will be offered to enroll in this study. The aim is to study 20 patients who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD between the ages of 21-65 years. Those subjects that receive sham stimulation will be offered to have active t-DCS stimulation for additional 3 weeks to get any benefit that they may have otherwise missed by being in the sham stimulation group. Results and Conclusions: The investigators will compare the mean baseline and end of treatment Montgomery Asberg depression rating scale between the two groups. The investigators will compare the change in mean depression scores between the baseline and end of treatment in those receiving active t-DCS for a total of 7 weeks duration. This study is innovative and of significance in exploring the role of this novel, easy to administer, safe and cost effective treatment modality.
Conditions Studied
Interventions
- DEVICE Transcranial direct current stimulation (t-DCS)
- OTHER Sham Controlled Arm
Study Locations (1)
Florida
- Univ of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-05 |
| Est. Completion | 2018-01-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02141776
The ClinicalTrials.gov registry entry for NCT02141776 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (99% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Transcranial direct current stimulation (t-DCS) is the first listed.
NCT02141776 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02141776 about?
NCT02141776 is a clinical study titled "Comparison of Anodal Transcranial Direct Current Stimulation (t-DCS) and Sham Stimulation in Patients With Treatment-resistant Depression". Major depressive disorder (MDD) is a significant public health problem. Existing treatment modalities are not always sufficient to alleviate this disorder. Treatment refractoriness is a common clinical problem. Transcranial direct current stimulation (t-DCS), a non-invasive brain stimulation techniq...
What is the current status of trial NCT02141776?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2014-05. Estimated completion is 2018-01-08.
What conditions does trial NCT02141776 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT02141776?
The interventions under investigation include: Transcranial direct current stimulation (t-DCS) (DEVICE), Sham Controlled Arm (OTHER).
Who is sponsoring clinical trial NCT02141776?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02141776 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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