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Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)

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ClinicalTrials.gov Identifier: NCT02452892
Recruitment Status : Completed
First Posted : May 25, 2015
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Tal Medical, Inc.

Brief Summary:
The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who are treatment resistant.

Condition or disease Intervention/treatment Phase
Depression Depressive Disorder Depressive Disorder, Treatment-resistant Depressive Disorder, Major Device: LFMS Not Applicable

Detailed Description:

The primary objective of this study:

  • To compare the relative efficacy, as measured by a change in the 6-item Hamilton Rating Scale for Depression (HAM-D6), of 20 and 60 minutes of LFMS compared to sham (placebo) in subjects with treatment resistant depression (TRD).

Secondary objectives:

  • To determine if subjects with TRD may respond to 120 minutes of LFMS.
  • To determine the persistence of response to LFMS therapy during the observation period.
  • To evaluate the safety and tolerability of LFMS.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Dose Optimization Study of Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: LFMS Sham
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Device: LFMS
Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
Other Name: Low Field Magnetic Stimulation

Active Comparator: LFMS 20 minutes
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Device: LFMS
Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
Other Name: Low Field Magnetic Stimulation

Active Comparator: LFMS 60 minutes
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Device: LFMS
Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
Other Name: Low Field Magnetic Stimulation

LFMS 120 min
Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Device: LFMS
Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
Other Name: Low Field Magnetic Stimulation




Primary Outcome Measures :
  1. Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score. [ Time Frame: Week 1 Day 4 ]

    Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline".

    Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more.



Secondary Outcome Measures :
  1. Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS [ Time Frame: Day 11 (Week 2) ]

    Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4".

    To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11.

    Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more.


  2. Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score [ Time Frame: Day 42 ]
    To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous ("yes or no") were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (Key)

  • Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for Major Depressive Disorder (MDD), as determined by psychiatric evaluation.
  • Has TRD of the current MDE, as assessed at the site by the Massachusetts General Hospital/Antidepressant Treatment Response Questionnaire (MGH/ATRQ).
  • On an adequate dose of one antidepressant therapy (ADT) for at least eight weeks prior to the screening visit (Visit 1). The ADT dose must be stable for at least four weeks prior to the screening visit (Visit 1). Subjects must be willing to remain on the same stable dose of ADT upon signing the informed consent form until the end of the treatment observation period (end of Week 2) and, where possible, to the end of study participation

Exclusion Criteria: (Key)

  • Have failed four or more lifetime adequate ADT treatment regimens (including the ongoing ADT for the current MDE).
  • Have been treated with adjunctive antipsychotic medication with an antidepressant for at least two weeks during the current depressive episode.
  • Are deemed to be at significant risk for suicidal behavior
  • Are unable to lie on their back for the duration of study treatment
  • Have a lifetime history of:

    1. Delirium, dementia, amnestic, or other cognitive disorder;
    2. Schizophrenia or any psychotic disorder, based on the Structured Clinical Interview for DSM-5 Axis I Disorders Patient Edition (SCID-I/P);
    3. Bipolar I or II disorder, based on the SCID-I/P.
  • Have a current DSM-5 diagnosis at the screening visit (Visit 1) of:

    1. An eating disorder active within the 12 months prior to the screening visit (Visit 1);
    2. Comorbid anxiety disorders that predominate over MDD, as assessed by the investigator;
    3. Alcohol or substance use disorder active within the 12 months prior to the screening visit (Visit 1);
    4. Clinically significant DSM-5 Axis II disorder.
  • Have ever received electroconvulsive therapy, vagal nerve stimulation, deep brain stimulation or repetitive transcranial magnetic stimulation.
  • Have a non-removable programmable device or appliance such as cardiac pacemakers or cochlear implants.
  • Have any non-removable ferromagnetic implants, or conductive or other magnetic sensitive materials present in the head or neck .
  • Have a lifetime history of seizures or clinically significant electroencephalography abnormalities. A history of childhood febrile seizures is permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452892


Locations
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United States, California
CNS Trials
Garden Grove, California, United States, 92845
Synergy Escondido
Lemon Grove, California, United States, 91945
Pacific Trials Partners
Oakland, California, United States, 94612
United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
CNS Healthcare
Jacksonville, Florida, United States, 32256
Segal Institute
Lauderhill, Florida, United States, 33319
United States, Georgia
Institute for Advanced Medical Research
Alpharetta, Georgia, United States, 30005
Radiant Research
Atlanta, Georgia, United States, 30328
United States, Ohio
Neurobehavioral-Clinical Research
Canton, Ohio, United States, 44718
Midwest Clinical
Dayton, Ohio, United States, 45417
United States, Texas
Future Search Trials
Dallas, Texas, United States, 75231
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Tal Medical, Inc.
Investigators
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Study Chair: Atul Pande, MD Tal Medical

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Responsible Party: Tal Medical, Inc.
ClinicalTrials.gov Identifier: NCT02452892     History of Changes
Other Study ID Numbers: TAL-02-007
First Posted: May 25, 2015    Key Record Dates
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Tal Medical, Inc.:
Depression
Major depression
Low-field magnetic stimulation
LFMS

Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders