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

Not Applicable

Completed

• Conditions: Treatment Resistant Depression
• Interventions: Device: Sham LFMS; Device: Low Field Magnetic Stimulation (LFMS)

• Registration Number: NCT01654796
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-08-01
• Study Start: 2013-04
• Primary Completion: 2016-05
• Study Completion: 2016-09
• Results First Submitted: 2017-04-17
• Results First Submitted QC: 2017-06-01
• Results First Posted: 2017-07-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham (LFMS)	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.
Low Field Magnetic Stimulation	Low Field Magnetic Stimulation (LFMS)	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.
Crossover Arm	Low Field Magnetic Stimulation (LFMS)	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.
Crossover Arm	Sham LFMS	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.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression - 6 Items	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.

Trial Locations

Locations (6)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Mount Sinai School of Medecine; 🇺🇸 New York, New York, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States