Treatment Resistant DepressionRAPIDNCT01654796

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

A study testing Low Field Magnetic Stimulation (LFMS) in people with Treatment Resistant Depression, run by Massachusetts General Hospital at 6 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

This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS) for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Treatment Resistant Depression
What is being tested?: Low Field Magnetic Stimulation (LFMS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 6 sitesUnited States
Study dates: Apr 2013to Sep 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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, 18-65 years old
Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks
A participant has Treatment Resistant Depression (TRD) of the current MDE
Good general health
For female participants, status of non-childbearing potential or use of an acceptable form of birth control
Body mass index between 18-40 kg/m2

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Concurrent psychotherapy will be allowed if the type and frequency of the therapy has been stable for at least three months prior to screening and is expected to remain stable during participation in the study
Concurrent hypnotic therapy will be allowed if the therapy has been stable for at least 4 weeks prior to screening and is expected to remain stable during the subject's participation in the study
Participant must be able to lie flat for 20 minutes

Who cannot join

A woman of childbearing potential who is not willing to use one of the specified forms of birth control during the study
Pregnant or breastfeeding
A woman with a positive pregnancy test at screening or baseline
Participant has TRD of the current MDE with failure to achieve a satisfactory response, as perceived by the subject, to more than 3 treatment courses of a therapeutic dose of an antidepressant therapy of at least eight weeks duration
Participant has a current diagnosis of a Substance Use Disorder with the exception of nicotine dependence, at screening or within six months prior to screening
Current diagnosis of Axis I disorders other than Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Specific Phobia, Post Traumatic Stress Disorder or Complicated Grief (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).

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Subject has a history of schizophrenia or schizoaffective disorders, any history of psychotic symptoms or is on antipsychotic medication for the treatment of psychotic symptoms
Subject has a history of eating disorders within five years of screening
Subject has any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant at any time within six months prior to screening
The participant is considered at significant risk for suicide during the study
Subject has had electroconvulsive therapy in the current episode of depression
Subject has had Transcranial Magnetic Stimulation or has received treatment with other experimental devices for the treatment of the current episode of depression
Subject has received Vagus Nerve Stimulation at any time
Dementia, delirium, amnestic, or other cognitive disorders
There is a clinically significant abnormality on the screening physical examination
Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation
Known history or current episode of:
--Uncontrolled hypertension, Recent myocardial infarction (within one year) or a history of more than one myocardial infarction, Syncopal event within the past year, Congestive heart failure, Angina pectoris
Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, or a history of significant head trauma within the past two years.
Lab abnormalities are present
History of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months prior to screening
Hisotry of hyperthyroidism which was treated (medically or sugically) less than six months prior to screening
Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with the interpretation of study results
History of positive screening urine test for drugs of abuse
Patient with any non-removable stimulation device such as neurostimulators, pacemakers and cochlear implants
Patients requiring treatment with excluded concomitant medications
Patients who cannot be in a MRI
Patients who are currently using a metal intrauterine device (IUD)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Texas Southwestern
Dallas, Texas, 75390
Yale University
New Haven, Connecticut, 06511
Mount Sinai School of Medecine
New York, New York, 10029

Other trials in United States

About this study

Official title: Double-Blind, Proof-of-Concept (POC) Trial of Low Field Magnetic Stimulation (LFMS) Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

Conditions: Treatment Resistant Depression
Being tested: Low Field Magnetic Stimulation (LFMS), Sham LFMS
Keywords: Depression, Treatment Resistant Depression
Medical subject headings: Depressive Disorder, Treatment-Resistant, Depression

What participants receive

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

Low Field Magnetic Stimulation (LFMS)Device
The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
Sham LFMSDevice
Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.

Study groups in NCT01654796
Study group	Role	What they receive
Low Field Magnetic Stimulation	Active comparator	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. Receives: Device: Low Field Magnetic Stimulation (LFMS)
Sham (LFMS)	Placebo comparator	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. Receives: Device: Sham LFMS
Crossover Arm	Other	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. Receives: Device: Low Field Magnetic Stimulation (LFMS); Device: Sham LFMS

What is being measured

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

Hamilton Rating Scale for Depression - 6 Items
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.
Measured: Baseline and 48 hours after initiating treatment

Timeline

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

Apr 2013Sep 2016

First posted1 Aug 2012 (estimated)
Study startApr 2013
Primary completionMay 2016
Study completionSep 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 Treatment Resistant DepressionStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
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: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01654796
Sponsor's protocol ID: 2012P001233
Acronym: RAPID
Status last verified: Aug 2017
First submitted: 30 Jul 2012
Last updated: 5 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

See locations

RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression

All Treatment Resistant Depression trials

Study at a glance

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

Official title: Double-Blind, Proof-of-Concept (POC) Trial of Low Field Magnetic Stimulation (LFMS) Augmentation of Antidepressant Therapy in Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT01654796
Acronym / sponsor ID: RAPID / 2012P001233
Conditions: Treatment Resistant Depression
Keywords: Depression, Treatment Resistant Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
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
Study start: Apr 2013 (actual)
Primary completion: May 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 1 Aug 2012 (estimated)
Results: Posted 2 Jul 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low Field Magnetic Stimulation	Active comparator	Device: Low Field Magnetic Stimulation (LFMS)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.
Sham (LFMS)	Placebo comparator	Device: Sham LFMSPatients 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.
Crossover Arm	Other	Device: Low Field Magnetic Stimulation (LFMS), Device: Sham LFMSPatients 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female, 18-65 years old
Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks
A participant has Treatment Resistant Depression (TRD) of the current MDE
Good general health
For female participants, status of non-childbearing potential or use of an acceptable form of birth control

Key exclusion criteria (28 listed)

A woman of childbearing potential who is not willing to use one of the specified forms of birth control during the study
Pregnant or breastfeeding
A woman with a positive pregnancy test at screening or baseline
Participant has TRD of the current MDE with failure to achieve a satisfactory response, as perceived by the subject, to more than 3 treatment courses of a therapeutic dose of an antidepressant therapy of at least eight weeks duration
Participant has a current diagnosis of a Substance Use Disorder with the exception of nicotine dependence, at screening or within six months prior to screening

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
Low Field Magnetic Stimulation (LFMS)The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.	Device	Crossover Arm, Low Field Magnetic Stimulation
Sham LFMSSham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.	Device	Crossover Arm, Sham (LFMS)

Primary outcome

Hamilton Rating Scale for Depression - 6 Items
Time frame: Baseline and 48 hours after initiating treatment
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.

Results and safety

Results posted to the registry on 2 Jul 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
Low Field Magnetic Stimulation	26	25
Sham (LFMS)	29	26
Sham LFMS First, Then Active LFMS	29	28

Primary outcome: Hamilton Rating Scale for Depression - 6 Items

Time frame: Baseline and 48 hours after initiating treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Phase 1 Active LFMS n = 26	Phase 1 Sham LFMS n = 58	Phase 2 Active LFMS n = 18	Phase 2 Sham LFMS n = 21
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)

Population analysed: Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Field Magnetic Stimulation	0 of 27 (0%)	22 of 27 (81.5%)	0 of 27
Sham (LFMS)	0 of 29 (0%)	18 of 29 (62.1%)	0 of 29
Crossover Arm	0 of 29 (0%)	20 of 29 (69%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Treatment Resistant Depression

RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression

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.

Dan Iosifescu, MD principal investigator

Mount Sinai School of Medecine

Gerald Sanacora, MD principal investigator

Yale University

Madhukar Trivedi, MD principal investigator

University of Texas

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

Questions about this trial

What is this clinical trial studying?

A study testing Low Field Magnetic Stimulation (LFMS) in people with Treatment Resistant Depression, run by Massachusetts General Hospital at 6 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 9 inclusion and 28 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 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 2 Jul 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?

Hamilton Rating Scale for Depression - 6 Items (time frame: Baseline and 48 hours after initiating treatment). 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 NCT01654796.

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 Sep 2017.