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: September 18, 2014
Last verified: September 2014

July 30, 2012
September 18, 2014
April 2013
August 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01654796 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of Low Field Magnetic Stimulation Augmentation of Antidepressant Therapy in Treatment-Resistant Depression
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 frequency magnetic stimulation (LFMS) for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Treatment Resistant Depression
  • 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.
  • 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.
    Intervention: Device: Low Frequency Magnetic Stimulation (LFMS)
  • Placebo Comparator: Sham (LFMS)
    4 days of sham (not active) low frequency magnetic stimulation (LFMS).
    Intervention: Device: Sham LFMS
  • Crossover Arm
    Patients in this group will receive two days of sham low frequency magnetic stimulation (LFMS) followed by two days of active LFMS.
    Interventions:
    • Device: Low Frequency Magnetic Stimulation (LFMS)
    • Device: Sham LFMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
September 2015
August 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01654796
2012P001233
Yes
Maurizio Fava, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • National Institute of Mental Health (NIMH)
  • Yale University
  • Mount Sinai School of Medicine
  • University of Texas Southwestern Medical Center
  • University of Alabama at Birmingham
  • Emory University
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
Massachusetts General Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP