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

NCT02452892 | Completed Results

• 1 other identifier: TAL-02-007
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 12

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.

Conditions

Depression; Depressive Disorder; Depressive Disorder, Treatment-resistant; Depressive Disorder, Major

Keywords

Depression; Major depression; Low-field magnetic stimulation; LFMS

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.

  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.

  Week 1 Day 4

Secondary Outcomes (2)

• Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS

  Day 11 (Week 2)

• Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score

  Day 42

Study Arms (4)

LFMS Sham

SHAM COMPARATOR

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

LFMS 20 minutes

ACTIVE COMPARATOR

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

LFMS 60 minutes

ACTIVE COMPARATOR

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

LFMS 120 min

OTHER

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

Interventions

LFMS DEVICE

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.

Also known as: Low Field Magnetic Stimulation

LFMS 120 min; LFMS 20 minutes; LFMS 60 minutes; LFMS Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Delirium, dementia, amnestic, or other cognitive disorder;
• Schizophrenia or any psychotic disorder, based on the Structured Clinical Interview for DSM-5 Axis I Disorders Patient Edition (SCID-I/P);
• Bipolar I or II disorder, based on the SCID-I/P.
• Have a current DSM-5 diagnosis at the screening visit (Visit 1) of:
• An eating disorder active within the 12 months prior to the screening visit (Visit 1);
• Comorbid anxiety disorders that predominate over MDD, as assessed by the investigator;
• Alcohol or substance use disorder active within the 12 months prior to the screening visit (Visit 1);
• 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.

Sponsors & Collaborators

• Tal Medical, Inc.: lead

Study Sites (12)

CNS Trials

Garden Grove, California, 92845, United States

Location

Synergy Escondido

Lemon Grove, California, 91945, United States

Location

Pacific Trials Partners

Oakland, California, 94612, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

Segal Institute

Lauderhill, Florida, 33319, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30005, United States

Location

Radiant Research

Atlanta, Georgia, 30328, United States

Location

Neurobehavioral-Clinical Research

Canton, Ohio, 44718, United States

Location

Midwest Clinical

Dayton, Ohio, 45417, United States

Location

Future Search Trials

Dallas, Texas, 75231, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Limitations and Caveats

The study was not powered for secondary measures. Statistical significance for group-wise comparisons wasn't expected.

Results Point of Contact

• Title: Dr. Atul Pande, MD, Chief Medical Officer
• Organization: Tal Medical

apande@talmedical.com

Study Officials

• Atul Pande, MD

  Tal Medical

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 25, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 5, 2017
• Results First Posted: December 5, 2017

Record last verified: 2017-09

Locations

US (12)