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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Yale University | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| University of Texas Southwestern Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Field Magnetic Stimulation | Active Comparator | 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. |
|
| Sham (LFMS) | Placebo Comparator | 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. |
|
| Crossover Arm | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Field Magnetic Stimulation (LFMS) | Device | The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression - 6 Items | 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 |
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Inclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States | ||
| Yale University |
Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data. Adverse events are reported for all 85 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| University of Alabama at Birmingham | OTHER |
| Emory University | OTHER |
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| Sham LFMS | Device | Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation. |
|
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mount Sinai School of Medecine | New York | New York | 10029 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| FG001 | 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. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation. |
| FG002 | Sham LFMS First, Then Active 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. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation. |
| COMPLETED |
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| NOT COMPLETED |
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Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. |
| BG001 | 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. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation. |
| BG002 | 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. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression - 6 Items | 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. | Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 48 hours after initiating treatment |
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The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. | 0 | 27 | 0 | 27 | 22 | 27 |
| EG001 | 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. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation. | 0 | 29 | 0 | 29 | 18 | 29 |
| EG002 | 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. Low Field Magnetic Stimulation (LFMS): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression. Sham LFMS: Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation. | 0 | 29 | 0 | 29 | 20 | 29 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Vascular disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Blood Pressure Increased | Vascular disorders | Systematic Assessment |
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| Disturbance in Attention | Psychiatric disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Somnolence | Psychiatric disorders | Systematic Assessment |
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| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Hot Flush | Vascular disorders | Systematic Assessment |
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| Memory Impairment | Psychiatric disorders | Systematic Assessment |
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| Myalgia | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Sleep Disorder | Psychiatric disorders | Systematic Assessment |
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| Abnormal Dreams | Psychiatric disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Apathy | Psychiatric disorders | Systematic Assessment |
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| Aphasia | Nervous system disorders | Systematic Assessment |
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| Bruxism | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Electrocardiogram Abnormal | Cardiac disorders | Systematic Assessment |
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| Fatigue | Psychiatric disorders | Systematic Assessment |
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| Hiccups | Nervous system disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Muscle Twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in Extremity | Nervous system disorders | Systematic Assessment |
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| Psychomotor Hyperactivity | Psychiatric disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Toothache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Abdominal Discomfort | General disorders | Systematic Assessment |
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| Abdominal Pain Lower | General disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Asthenia | Nervous system disorders | Systematic Assessment |
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| Confusional State | Psychiatric disorders | Systematic Assessment |
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| Decreased Appetite | General disorders | Systematic Assessment |
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| Dehydration | General disorders | Systematic Assessment |
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| Drooling | General disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Flushing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Gastrointestinal Disorder | Gastrointestinal disorders | Systematic Assessment |
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| Heart Rate Increased | Cardiac disorders | Systematic Assessment |
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| Hyperlycemia | Endocrine disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Hypoglycemia | Endocrine disorders | Systematic Assessment |
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| Hypokalemia | Renal and urinary disorders | Systematic Assessment |
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| Libido Decreased | General disorders | Systematic Assessment |
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| Medial Tibial Stress Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle Tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myodesopsia | Eye disorders | Systematic Assessment |
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| Nightmare | Psychiatric disorders | Systematic Assessment |
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| Obsessive-Compulsive Disorder | Psychiatric disorders | Systematic Assessment |
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| Orgasm Abnormal | General disorders | Systematic Assessment |
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| Parathyroid Tumor Benign | Endocrine disorders | Systematic Assessment |
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| Presyncope | Vascular disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Restlessness | Psychiatric disorders | Systematic Assessment |
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| Sinus Congestion | General disorders | Systematic Assessment |
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| Sinus Headache | General disorders | Systematic Assessment |
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| Syncope | Vascular disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Tension | General disorders | Systematic Assessment |
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| Tooth Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Ventricular Extrasystoles | Cardiac disorders | Systematic Assessment |
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| Vision Blurred | Eye disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Weight Decreased | General disorders | Systematic Assessment |
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| Weight Increased | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maurizio Fava | Massachusetts General Hospital | 617-724-2513 | MFAVA@mgh.harvard.edu |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| End of Phase |
|
| Score Change |
|