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NCT01343563 · ClinicalTrials.gov registry record · Phase 2
Trigeminal Nerve Stimulation for Depression: Dose Finding
A Phase 2 study of Depression, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01343563: Completed Phase 2 study of Depression, sponsored by University of California, Los Angeles.
NCT01343563 is a Phase 2 study of Depression that has completed, run by University of California, Los Angeles. The registered enrollment target is 20 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343563, a Phase 2 study of Depression, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) when added onto antidepressant medications. Our primary objective is the examination of two different "doses" of TNS, in terms of pulse frequency. To accomplish our specific aims, the investigators will test the following specific hypotheses: 1. Subjects will show greater improvement in ratings of mood and other symptoms of depression during the six-week of high frequency stimulation than during low frequency stimulation periods. 2. Subjects will show greater improvement after 12 weeks of high frequency stimulation than after six weeks of high frequency stimulation. 3. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS. 4. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device. 5. Subjects will show significant differences in regional brain function at the end of the high frequency stimulation period compared with baseline, and significant differences between high and low frequency stimulation conditions.
Conditions Studied
Interventions
- PROCEDURE Trigeminal Nerve Stimulation
Study Locations (1)
California
- Semel Institute for Neuroscience and Human Behavior at UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT01343563 record still lists
NCT01343563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Trigeminal Nerve Stimulation is the first listed.
NCT01343563 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01343563 about?
NCT01343563 is a clinical study titled "Trigeminal Nerve Stimulation for Depression: Dose Finding". This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) when added onto antidepressant medications. Our primary objective is the examination of two different "doses" of TNS, in terms of pulse fre...
What is the current status of trial NCT01343563?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-01. Estimated completion is 2012-01.
What conditions does trial NCT01343563 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT01343563?
The interventions under investigation include: Trigeminal Nerve Stimulation (PROCEDURE).
Who is sponsoring clinical trial NCT01343563?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01343563 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01343563's enrollment target sits among peer trials
20 612th of 679 higher than 58 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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