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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Yale University
Mount Sinai School of Medicine
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
Emory University
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01654796
First received: July 30, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Treatment Resistant Depression
Device: Low Frequency Magnetic Stimulation (LFMS)
Device: Sham LFMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Proof-of-Concept (POC) Trial of Low Field Magnetic Stimulation (LFMS) Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression - 6 items [ Time Frame: past 24 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Frequency Magnetic Stimulation
Patients in this arm will receive 4 days of active low frequency magnetic stimulation (LFMS) treatment, 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 Frequency Magnetic Stimulation (LFMS)
The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Placebo Comparator: Sham (LFMS)
4 days of sham (not active) low frequency magnetic stimulation (LFMS).
Device: Sham LFMS
SHam LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
Crossover Arm
Patients in this group will receive two days of sham low frequency magnetic stimulation (LFMS) followed by two days of active LFMS.
Device: Low Frequency 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 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

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 >3 treatment courses of a therapeutic dose of an antidepressant therapy at least six 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 in 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

  • Chronic lung disease
  • Lifetime history of surgical procedures involving the brain or meninges encephalitis, meningitis, degenerative central nervous system disorder, epilepsy, mental retardation, any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, history of significant head trauma within the past two years, or is currently receiving anticonvulsant therapy
  • Lab abnormalities are present
  • History of hypothyroidism and has been on a stable dosage of thyroid replacement medication, or was surgically treated 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
  • Patients requiring treatment with excluded concomitant medications
  • Patients who cannot be in a MRI
  • Patients who are unable to lie on their back for 20 minutes or more
  • Patients who are currently using a metal intrauterine device (IUD)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654796

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Mount Sinai School of Medecine
New York, New York, United States, 10029
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Massachusetts General Hospital
Yale University
Mount Sinai School of Medicine
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
Emory University
Investigators
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: Maurizio Fava, MD Massachusetts General Hospital (Coordinating Center)
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
  More Information

No publications provided

Responsible Party: Maurizio Fava, MD, Overall Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01654796     History of Changes
Other Study ID Numbers: 2012P001233
Study First Received: July 30, 2012
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Massachusetts General Hospital:
Depression
Treatment Resistant Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014