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NCT01370733 · ClinicalTrials.gov registry record · Phase 3

Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder

A Phase 3 study of Major Depressive Disorder, sponsored by Wave Neuroscience.

Completed
Registry status
Phase 3
Development phase
202
Enrollment target
18
Study locations

NCT01370733 is a Phase 3 study of Major Depressive Disorder that has completed, run by Wave Neuroscience. The registered enrollment target is 202 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (46% lower). The trial reports 18 study locations across 13 states.

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The verdict

NCT01370733, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Wave Neuroscience.

COMPLETED
Registry status
Phase 3
Development phase
202 participants
Enrollment target
18
Study locations

Study Summary

This study is designed to evaluate the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Major Depressive Disorder. This is a multicenter study in which subjects will be randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy or antidepressant medications during the follow-up phase of the study. Follow-up evaluation visits will be conducted during those four weeks, with the frequency of the visits determined by the treatment choice during that timeframe.

Conditions Studied

Interventions

  • DEVICE SHAM
  • DEVICE NEST-1 (NeoSync EEG Synchronized TMS)

Study Locations (18)

California

  • UCLA Depression Research & Clinic Program - Los Angeles
  • UCSD Medical Center - San Diego
  • UCLA-Harbor - Torrance

North Carolina

  • Duke University Brain Stimulation and Neurophysiology Center - Durham
  • Wake Forest University Medical Center - Winston-Salem

Pennsylvania

  • University of Pennsylvania - Philadelphia
  • Mood Disorders Treatment Research Program University of Pittsburgh-Western Psychiatric Institute and Clinic - Pittsburgh

Texas

  • UT Southwestern Medical Center - Dallas
  • R/D Clinical Research - Lake Jackson

Connecticut

  • Hartford Hospital Institute of Living - Hartford

Illinois

  • TMS Specialists Chicago - Chicago

Maryland

  • Sheppard Pratt Health System - Baltimore

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 202 participants
Start Date 2012-05
Est. Completion 2013-09
Phase Phase 3

Sponsor

Wave Neuroscience

11 total trials

What the Registry Record Tells You About NCT01370733

The ClinicalTrials.gov registry entry for NCT01370733 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (46% lower). The listed sponsor is Wave Neuroscience, which has 11 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 SHAM is the first listed.

NCT01370733 reports 18 study locations spanning 13 distinct geographic areas - top geographies include California, North Carolina, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01370733 about?

NCT01370733 is a clinical study titled "Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder". This study is designed to evaluate the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Major Depressive Disorder. This is a multicenter study in which subjects will be randomized to receive treatment 5...

What is the current status of trial NCT01370733?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2012-05. Estimated completion is 2013-09.

What conditions does trial NCT01370733 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT01370733?

The interventions under investigation include: SHAM (DEVICE), NEST-1 (NeoSync EEG Synchronized TMS) (DEVICE).

Who is sponsoring clinical trial NCT01370733?

This trial is sponsored by Wave Neuroscience, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01370733 being conducted?

This trial has 18 study locations across California, Connecticut, Illinois, Maryland, Missouri. 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 Editorial

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.