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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01654796
Recruitment Status : Completed
First Posted : August 1, 2012
Results First Posted : July 2, 2017
Last Update Posted : September 5, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Yale University
Icahn School of Medicine at Mount Sinai
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
Emory University
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Treatment Resistant Depression
Interventions Device: Low Field Magnetic Stimulation (LFMS)
Device: Sham LFMS
Enrollment 84
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Low Field Magnetic Stimulation Sham (LFMS) Sham LFMS First, Then Active LFMS
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 26 29 29
Completed 25 26 28
Not Completed 1 3 1
Arm/Group Title Low Field Magnetic Stimulation Sham (LFMS) Crossover Arm Total
Hide Arm/Group Description

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 26 29 29 84
Hide Baseline Analysis Population Description
Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 29 participants 29 participants 84 participants
47.9  (14.8) 50.7  (10) 46.3  (14.6) 48.3  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 29 participants 84 participants
Female
15
  57.7%
17
  58.6%
15
  51.7%
47
  56.0%
Male
11
  42.3%
12
  41.4%
14
  48.3%
37
  44.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 29 participants 84 participants
Hispanic or Latino
1
   3.8%
1
   3.4%
0
   0.0%
2
   2.4%
Not Hispanic or Latino
25
  96.2%
28
  96.6%
29
 100.0%
82
  97.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 29 participants 84 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
  10.3%
0
   0.0%
3
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  23.1%
6
  20.7%
3
  10.3%
15
  17.9%
White
20
  76.9%
19
  65.5%
25
  86.2%
64
  76.2%
More than one race
0
   0.0%
1
   3.4%
1
   3.4%
2
   2.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Hamilton Rating Scale for Depression – 6 Items
Hide Description 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.
Time Frame Baseline and 48 hours after initiating treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.
Arm/Group Title Phase 1 Active LFMS Phase 1 Sham LFMS Phase 2 Active LFMS Phase 2 Sham LFMS
Hide Arm/Group Description:
Participants in this group receive Active LFMS treatment for 2 days in Phase 1.
Participants in this group received Sham LFMS treatment for 2 days in Phase 1.
Participants in this group received Active LFMS treatment for 2 days in Phase 2.
Participants in this group received Sham LFMS treatment for 2 days in Phase 2.
Overall Number of Participants Analyzed 26 58 18 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 11.7  (2.2) 11.3  (2.1) 10.9  (2.2) 9.4  (2.3)
End of Phase 8.8  (2.5) 8.1  (3.7) 9.6  (3.9) 8.0  (3.7)
Score Change -2.8  (2.5) -3.2  (3.3) -1.3  (3.7) -1.5  (2.4)
Time Frame [Not Specified]
Adverse Event Reporting Description The adverse events listed include information for all 85 randomized subjects. Only 84 subjects were included in the outcome analysis due to missing data.
 
Arm/Group Title Low Field Magnetic Stimulation Sham (LFMS) Crossover Arm
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Low Field Magnetic Stimulation Sham (LFMS) Crossover Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/29 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Low Field Magnetic Stimulation Sham (LFMS) Crossover Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/29 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Field Magnetic Stimulation Sham (LFMS) Crossover Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/27 (81.48%)      18/29 (62.07%)      20/29 (68.97%)    
Cardiac disorders       
Palpitations   0/27 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  2
Electrocardiogram Abnormal   1/27 (3.70%)  1 1/29 (3.45%)  1 0/29 (0.00%)  0
Heart Rate Increased   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Tachycardia   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Ventricular Extrasystoles   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Ear and labyrinth disorders       
Tinnitus   1/27 (3.70%)  1 0/29 (0.00%)  0 1/29 (3.45%)  1
Endocrine disorders       
Hyperlycemia   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Hypoglycemia   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Parathyroid Tumor Benign   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Eye disorders       
Myodesopsia   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Vision Blurred   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Gastrointestinal disorders       
Diarrhea   1/27 (3.70%)  1 2/29 (6.90%)  2 1/29 (3.45%)  1
Nausea   1/27 (3.70%)  1 1/29 (3.45%)  1 2/29 (6.90%)  2
Constipation   0/27 (0.00%)  0 3/29 (10.34%)  3 0/29 (0.00%)  0
Dry Mouth   1/27 (3.70%)  1 1/29 (3.45%)  1 1/29 (3.45%)  1
Dyspepsia   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Gastrointestinal Disorder   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Vomiting   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
General disorders       
Abdominal Discomfort   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Abdominal Pain Lower   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Decreased Appetite   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Dehydration   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Drooling   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Libido Decreased   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Orgasm Abnormal   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Sinus Congestion   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Sinus Headache   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Tension   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Weight Decreased   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Weight Increased   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain   1/27 (3.70%)  1 1/29 (3.45%)  1 1/29 (3.45%)  1
Bruxism   0/27 (0.00%)  0 2/29 (6.90%)  2 0/29 (0.00%)  0
Muscle Twitching   0/27 (0.00%)  0 0/29 (0.00%)  0 2/29 (6.90%)  2
Toothache   0/27 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
Medial Tibial Stress Syndrome   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Muscle Spasms   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Muscle Tightness   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Tooth Fracture   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Nervous system disorders       
Headache   6/27 (22.22%)  9 10/29 (34.48%)  17 5/29 (17.24%)  7
Paraesthesia   0/27 (0.00%)  0 1/29 (3.45%)  3 2/29 (6.90%)  2
Myalgia   1/27 (3.70%)  1 0/29 (0.00%)  0 2/29 (6.90%)  3
Aphasia   1/27 (3.70%)  1 1/29 (3.45%)  1 0/29 (0.00%)  0
Dysgeusia   1/27 (3.70%)  1 1/29 (3.45%)  1 0/29 (0.00%)  0
Hiccups   0/27 (0.00%)  0 1/29 (3.45%)  2 0/29 (0.00%)  0
Migraine   0/27 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
Pain in Extremity   1/27 (3.70%)  1 1/29 (3.45%)  1 0/29 (0.00%)  0
Asthenia   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Hypoaesthesia   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Tremor   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Psychiatric disorders       
Irritability   2/27 (7.41%)  2 2/29 (6.90%)  2 3/29 (10.34%)  3
Insomnia   0/27 (0.00%)  0 2/29 (6.90%)  2 4/29 (13.79%)  4
Disturbance in Attention   2/27 (7.41%)  2 2/29 (6.90%)  2 1/29 (3.45%)  1
Somnolence   2/27 (7.41%)  2 1/29 (3.45%)  1 1/29 (3.45%)  2
Memory Impairment   2/27 (7.41%)  2 1/29 (3.45%)  1 1/29 (3.45%)  1
Sleep Disorder   1/27 (3.70%)  2 1/29 (3.45%)  1 1/29 (3.45%)  1
Abnormal Dreams   2/27 (7.41%)  2 0/29 (0.00%)  0 1/29 (3.45%)  1
Anxiety   1/27 (3.70%)  1 1/29 (3.45%)  1 0/29 (0.00%)  0
Apathy   0/27 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
Fatigue   0/27 (0.00%)  0 1/29 (3.45%)  1 1/29 (3.45%)  1
Psychomotor Hyperactivity   1/27 (3.70%)  1 1/29 (3.45%)  1 0/29 (0.00%)  0
Confusional State   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Nightmare   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Obsessive-Compulsive Disorder   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Restlessness   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Renal and urinary disorders       
Pollakiuria   2/27 (7.41%)  2 1/29 (3.45%)  1 0/29 (0.00%)  0
Hypokalemia   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Tract Infection   2/27 (7.41%)  2 1/29 (3.45%)  1 2/29 (6.90%)  2
Nasopharyngitis   2/27 (7.41%)  2 1/29 (3.45%)  1 0/29 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Flushing   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Rash   0/27 (0.00%)  0 0/29 (0.00%)  0 1/29 (3.45%)  1
Vascular disorders       
Dizziness   1/27 (3.70%)  2 2/29 (6.90%)  4 2/29 (6.90%)  2
Blood Pressure Increased   0/27 (0.00%)  0 1/29 (3.45%)  4 1/29 (3.45%)  1
Hot Flush   4/27 (14.81%)  4 0/29 (0.00%)  0 0/29 (0.00%)  0
Presyncope   1/27 (3.70%)  1 0/29 (0.00%)  0 0/29 (0.00%)  0
Syncope   0/27 (0.00%)  0 1/29 (3.45%)  1 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Maurizio Fava
Organization: Massachusetts General Hospital
Phone: 617-724-2513
Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01654796     History of Changes
Other Study ID Numbers: 2012P001233
First Submitted: July 30, 2012
First Posted: August 1, 2012
Results First Submitted: April 17, 2017
Results First Posted: July 2, 2017
Last Update Posted: September 5, 2017