DepressionNCT02452892

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

A study testing LFMS in people with Depression and Depressive Disorder, run by Tal Medical, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression, Depressive Disorder, Depressive Disorder, Treatment-resistant
What is being tested?: LFMS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 12 sitesUnited States
Study dates: Sep 2015to Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 17Show fewer

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.
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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Institute for Advanced Medical Research
Alpharetta, Georgia, 30005
Radiant Research
Atlanta, Georgia, 30328
Northwest Clinical Research Center
Bellevue, Washington, 98007
Neurobehavioral-Clinical Research
Canton, Ohio, 44718
Future Search Trials
Dallas, Texas, 75231
Midwest Clinical
Dayton, Ohio, 45417
Sarkis Clinical Trials
Gainesville, Florida, 32607
CNS Trials
Garden Grove, California, 92845
CNS Healthcare
Jacksonville, Florida, 32256
Segal Institute
Lauderhill, Florida, 33319
Synergy Escondido
Lemon Grove, California, 91945
Pacific Trials Partners
Oakland, California, 94612

Other trials in United States

About this study

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)

Read the 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.

Conditions: Depression, Depressive Disorder, Depressive Disorder, Treatment-resistant, Depressive Disorder, Major
Being tested: LFMS
Keywords: Depression, Major depression, Low-field magnetic stimulation, LFMS
Medical subject headings: Depression, Depressive Disorder, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LFMSDevice
Also called Low Field Magnetic Stimulation
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.

Study groups in NCT02452892
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: LFMS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Day 11 (Week 2)
Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score
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.
Measured: Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Oct 2016

First posted25 May 2015 (estimated)
Study startSep 2015
Primary completionSep 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02452892
Sponsor's protocol ID: TAL-02-007
Status last verified: Sep 2017
First submitted: 19 May 2015
Last updated: 5 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02452892
Acronym / sponsor ID: TAL-02-007
Conditions: Depression, Depressive Disorder, Depressive Disorder, Treatment-resistant, Depressive Disorder, Major
Keywords: Depression, Major depression, Low-field magnetic stimulation, LFMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Tal Medical, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Sep 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 25 May 2015 (estimated)
Results: Posted 5 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
LFMS Sham	Sham comparator	Device: LFMSFor 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.
LFMS 20 minutes	Active comparator	Device: LFMSLFMS 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.
LFMS 60 minutes	Active comparator	Device: LFMSLFMS 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.
LFMS 120 min	Other	Device: LFMSWeek 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (17 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LFMSAlso: Low Field Magnetic StimulationLow 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.	Device	LFMS 120 min, LFMS 20 minutes, LFMS 60 minutes, LFMS Sham

Primary outcome

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.

2 secondary outcomes

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)
Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score
Time frame: Day 42

Results and safety

Results posted to the registry on 5 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LFMS Sham	41	40
LFMS 20 Minutes	40	40
LFMS 60 Minutes	41	40
LFMS 120 Min	0	0

Primary outcome: 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. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	LFMS Sham n = 41	LFMS 20 Minutes n = 40	LFMS 60 Minutes n = 41
Value	-4.0 (-5.18 to -2.91)	-4.2 (-5.34 to -3.04)	-4.9 (-6.03 to -3.73)

LFMS Sham vs LFMS 60 Minutes: p = 0.307, Mixed Models Analysis
LFMS Sham vs LFMS 20 Minutes: p = 0.859, Mixed Models Analysis

Population analysed: Subjects in the All Randomized set who completed at least one treatment session and had at least one post baseline primary efficacy assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LFMS Sham	0 of 79 (0%)	20 of 79 (25.3%)	0 of 79
LFMS 20 Minutes	0 of 40 (0%)	14 of 40 (35%)	0 of 40
LFMS 60 Minutes	0 of 41 (0%)	13 of 41 (31.7%)	0 of 41
LFMS 120 Min - Week 2	0 of 41 (0%)	10 of 41 (24.4%)	0 of 41

Limitations and caveats (from the sponsor): The study was not powered for secondary measures. Statistical significance for group-wise comparisons wasn't expected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Atul Pande, MD study chair

Tal Medical

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LFMS in people with Depression and Depressive Disorder, run by Tal Medical, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02452892.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.