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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 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.

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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

Depression

Interventions

  • PROCEDURE Trigeminal Nerve Stimulation

Study Locations (1)

California

  • Semel Institute for Neuroscience and Human Behavior at UCLA - Los Angeles

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-01
Est. Completion 2012-01
Phase Phase 2

Sponsor

University of California, Los Angeles

897 total trials

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What the Registry Record Tells You About NCT01343563

The ClinicalTrials.gov registry entry for NCT01343563 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.