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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01654796
First received: July 30, 2012
Last updated: August 2, 2017
Last verified: August 2017
Results First Received: April 17, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

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.

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.


Participant Flow:   Overall Study
    Low Field Magnetic Stimulation   Sham (LFMS)   Sham LFMS First, Then Active LFMS
STARTED   26   29   29 
COMPLETED   25   26   28 
NOT COMPLETED   1   3   1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.

Reporting Groups
  Description
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.

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.

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.

Total Total of all reporting groups

Baseline Measures
   Low Field Magnetic Stimulation   Sham (LFMS)   Crossover Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   29   29   84 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.9  (14.8)   50.7  (10)   46.3  (14.6)   48.3  (13.3) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Hamilton Rating Scale for Depression – 6 Items   [ Time Frame: Baseline and 48 hours after initiating treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: MFAVA@mgh.harvard.edu



Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01654796     History of Changes
Other Study ID Numbers: 2012P001233
Study First Received: July 30, 2012
Results First Received: April 17, 2017
Last Updated: August 2, 2017