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

NCT01654796 | Completed Results DMC

• 1 other identifier: 2012P001233
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 6

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

Keywords

Depression; Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 48 hours after initiating treatment

Study Arms (3)

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.

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.

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.

Device: Low Field Magnetic Stimulation (LFMS); Device: Sham LFMS

Interventions

Low Field Magnetic Stimulation (LFMS) DEVICE

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

Crossover Arm; Low Field Magnetic Stimulation

Sham LFMS DEVICE

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

Crossover Arm; Sham (LFMS)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Yale University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• University of Texas Southwestern Medical Center: collaborator
• University of Alabama at Birmingham: collaborator
• Emory University: collaborator

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mount Sinai School of Medecine

New York, New York, 10029, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Maurizio Fava
• Organization: Massachusetts General Hospital

MFAVA@mgh.harvard.edu

617-724-2513

Study Officials

• Dan Iosifescu, MD

  Mount Sinai School of Medecine

  PRINCIPAL INVESTIGATOR

• Gerald Sanacora, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Madhukar Trivedi, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Maurizio Fava, MD

  Massachusetts General Hospital (Coordinating Center)

  PRINCIPAL INVESTIGATOR

• Mark Rapaport, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Richard Shelton, MD

  Univsity of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• George I Papakostas, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

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: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Overall Principal Investigator

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 5, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-08

Locations

US (6)