Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder



Status:Active, not recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:22 - 65
Updated:1/18/2019
Start Date:November 27, 2017
End Date:June 2019

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Trial Summary
Trial Overview
Inclusion Criteria

A Prospective, Multicenter, Double-Blind, Sham-Controlled Adaptive Design Study to Confirm the Safety and Efficacy of NEST sTMS in Subjects With Major Depressive Disorder Who Have Not Responded to at Least One Antidepressant Medication in the Current Episode

This is a double-blind, sham controlled, multi-center study to confirm the safety and
efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of
patients currently experiencing an episode of depression who have failed to respond to at
least one (1) antidepressant medication. Patients will be randomly assigned to either active
or sham therapy and will undergo daily treatments for a period of time. Following completion
of blinded treatments, patients may be eligible for a course of open label treatments.


Inclusion Criteria:

- Current episode of Major Depressive Disorder

- Inadequate response to at least one antidepressant medication in the current episode
(Treatment Resistant Depression)

- Investigator able to identify IAF using EEG

- Willingness and ability to adhere to treatment schedule (5 treatments per week for six
weeks)

Exclusion Criteria:

- Unable to unwilling to give informed consent

- Diagnosed with excluded conditions or treatment histories

- Currently hospitalized due to severity of depression symptoms

- Use of prohibited medications (as defined by protocol) within specified time frame of
randomization

- Use of certain cardiac devices

- Use of certain intracranial devices

- Currently pregnant or unwilling to practice acceptable means of birth control, and
women who are breastfeeding
We found this trial at
14
sites
The Mayo Clinic
Rochester, Minnesota 55905
Principal Investigator: Paul Croarkin, DO
Phone: 507-284-5914
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Rochester, MN
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Emory University
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: William McDonald, MD
Phone: 404-712-6942
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Beth Israel Deaconess Medical Center
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Adam Stern, MD
Phone: 617-667-8412
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Sheppard Pratt Health System
Baltimore, Maryland 21285
Principal Investigator: Scott Aaronson, MD
Phone: 410-938-3135
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Baltimore, MD
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University of Texas Southwestern Medical Center
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Mustafa Husain, MD
Phone: 214-648-2820
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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Brain Health Consultants
24 Greenway Plaza
Houston, Texas 77046
Principal Investigator: Lauren Marangell, MD
Phone: 713-489-5000
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Houston, TX
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Kadima Neuropsychiatry Institute
3252 Holiday Court
La Jolla, California 92037
Principal Investigator: David Feifel, MD
Phone: 858-412-4130
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mi
from
La Jolla, CA
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UCLA Westwood - Semel Institute for Neuroscience and Human Behavior
760 Westwood Plaza
Los Angeles, California 90024
Principal Investigator: David Krantz, MD
Phone: 310-825-4781
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mi
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Los Angeles, CA
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New York University
70 Washington Square S
New York, New York 10012
(212) 998-1212
Principal Investigator: Dan Iosifescu, MD
Phone: 646-754-2211
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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New York, NY
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Univ of Pennsylvania
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael Thase, MD
Phone: 215-898-7253
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Butler Hospital
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Linda Carpenter, MD
Phone: 401-455-6547
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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Providence, RI
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Washington University/ Barnes-Jewish Hospital
Saint Louis, Missouri 63110
Principal Investigator: Charles Conway, MD
Phone: 314-273-1921
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Saint Louis, MO
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Stanford University
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Mahendra Bhati, MD
Phone: 650-646-5138
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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Laureate Institute for Brain Research
Tulsa, Oklahoma 74136
Principal Investigator: Yoon Hee Cha, MD
Phone: 918-502-5122
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mi
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Tulsa, OK
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