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

NCT ID: NCT01654796

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-09-30

Brief 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.

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Low Field Magnetic Stimulation (LFMS)

Intervention Type: DEVICE

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.

Group Type: PLACEBO_COMPARATOR

Sham LFMS

Intervention Type: DEVICE

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.

Group Type: OTHER

Low Field Magnetic Stimulation (LFMS)

Intervention Type: DEVICE

The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.

Sham LFMS

Intervention Type: DEVICE

Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.

Interventions

Low Field Magnetic Stimulation (LFMS)

The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.

Intervention Type: DEVICE

Sham LFMS

Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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).
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maurizio Fava, MD

Overall Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dan Iosifescu, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai School of Medecine

Gerald Sanacora, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Madhukar Trivedi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Maurizio Fava, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital (Coordinating Center)

Mark Rapaport, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Richard Shelton, MD

Role: PRINCIPAL_INVESTIGATOR

Univsity of Alabama at Birmingham

George I Papakostas, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Yale University

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mount Sinai School of Medecine

New York, New York, United States

University of Texas Southwestern

Dallas, Texas, United States

Countries

United States

Other Identifiers

2012P001233

Identifier Type: -

Identifier Source: org_study_id