Trial of Low Field Magnetic Stimulation Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

Summary

This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS) for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Conditions

• Treatment Resistant Depression

Interventions

DEVICE

Low Field Magnetic Stimulation (LFMS)

The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.

DEVICE

Sham LFMS

Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Yale University

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Emory University

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Dan Iosifescu, MD · Mount Sinai School of Medecine

• Gerald Sanacora, MD · Yale University

• Madhukar Trivedi, MD · University of Texas

• Maurizio Fava, MD · Massachusetts General Hospital (Coordinating Center)

• Mark Rapaport, MD · Emory University

• Richard Shelton, MD · Univsity of Alabama at Birmingham

• George I Papakostas, MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2016-05-31

Completion

2016-09-30

Countries

• United States

Study Locations