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

August 2, 2017 updated by: Maurizio Fava, MD, Massachusetts General Hospital

Double-Blind, Proof-of-Concept (POC) Trial of Low Field Magnetic Stimulation (LFMS) Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medecine
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, 18-65 years old
  • Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks
  • A participant has Treatment Resistant Depression (TRD) of the current MDE
  • Good general health
  • For female participants, status of non-childbearing potential or use of an acceptable form of birth control
  • Body mass index between 18-40 kg/m2
  • Concurrent psychotherapy will be allowed if the type and frequency of the therapy has been stable for at least three months prior to screening and is expected to remain stable during participation in the study
  • Concurrent hypnotic therapy will be allowed if the therapy has been stable for at least 4 weeks prior to screening and is expected to remain stable during the subject's participation in the study
  • Participant must be able to lie flat for 20 minutes

Exclusion Criteria:

  • A woman of childbearing potential who is not willing to use one of the specified forms of birth control during the study
  • Pregnant or breastfeeding
  • A woman with a positive pregnancy test at screening or baseline
  • Participant has TRD of the current MDE with failure to achieve a satisfactory response, as perceived by the subject, to more than 3 treatment courses of a therapeutic dose of an antidepressant therapy of at least eight weeks duration
  • Participant has a current diagnosis of a Substance Use Disorder with the exception of nicotine dependence, at screening or within six months prior to screening
  • Current diagnosis of Axis I disorders other than Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Specific Phobia, Post Traumatic Stress Disorder or Complicated Grief (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
  • Subject has a history of schizophrenia or schizoaffective disorders, any history of psychotic symptoms or is on antipsychotic medication for the treatment of psychotic symptoms
  • Subject has a history of eating disorders within five years of screening
  • Subject has any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant at any time within six months prior to screening
  • The participant is considered at significant risk for suicide during the study
  • Subject has had electroconvulsive therapy in the current episode of depression
  • Subject has had Transcranial Magnetic Stimulation or has received treatment with other experimental devices for the treatment of the current episode of depression
  • Subject has received Vagus Nerve Stimulation at any time
  • Dementia, delirium, amnestic, or other cognitive disorders
  • There is a clinically significant abnormality on the screening physical examination
  • Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation

  • Known history or current episode of:

    --Uncontrolled hypertension, Recent myocardial infarction (within one year) or a history of more than one myocardial infarction, Syncopal event within the past year, Congestive heart failure, Angina pectoris

  • Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, or a history of significant head trauma within the past two years.
  • Lab abnormalities are present
  • History of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months prior to screening
  • Hisotry of hyperthyroidism which was treated (medically or sugically) less than six months prior to screening
  • Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with the interpretation of study results
  • History of positive screening urine test for drugs of abuse
  • Patient with any non-removable stimulation device such as neurostimulators, pacemakers and cochlear implants
  • Patients requiring treatment with excluded concomitant medications
  • Patients who cannot be in a MRI
  • Patients who are currently using a metal intrauterine device (IUD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Low Field Magnetic Stimulation
Patients in this arm will receive 2 days of active low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of active low field magnetic stimulation (LFMS) in phase 2. LFMS is a novel, non-contact neuromodulation technique. LFMS is administered through a device while the patient lies on his/her back for 20 minutes.
Device: Low Field Magnetic Stimulation (LFMS)
The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Placebo Comparator: Sham (LFMS)
Patients in this arm will receive 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by 2 days of sham (not active) low field magnetic stimulation (LFMS) in phase 2.
Device: Sham LFMS
Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
Other: Crossover Arm
Patients in this group will receive two days of sham (not active) low field magnetic stimulation (LFMS) in phase 1, followed by two days of active low field magnetic stimulation (LFMS) in phase 2.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression - 6 Items
Time Frame: Baseline and 48 hours after initiating treatment
The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.
Baseline and 48 hours after initiating treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Yale University
University of Alabama at Birmingham
Icahn School of Medicine at Mount Sinai
Emory University
University of Texas Southwestern Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dan Iosifescu, MD, Mount Sinai School of Medecine
  • Principal Investigator: Gerald Sanacora, MD, Yale University
  • Principal Investigator: Madhukar Trivedi, MD, University of Texas
  • Principal Investigator: Mark Rapaport, MD, Emory University
  • Principal Investigator: Richard Shelton, MD, Univsity of Alabama at Birmingham
  • Principal Investigator: George I Papakostas, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012P001233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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