Low Field Magnetic Stimulation for Treatment Resistant Depression

NCT01944644 | Completed Results FDA Device

• 1 other identifier: 1207012777
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized, sham-controlled phase II study of the effects of Low Field Magnetic Stimulation (LFMS) on brain circuitry of adults with treatment-resistant Major Depressive Disorder (MDD). Eligible subjects will be randomly assigned to double-blind treatment with three 20 minute sessions of either (1) active LFMS or (2) sham LFMS. Resting state fMRI will be performed at baseline and following the third and final treatment session.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (4)

• 6 Item Hamilton Depression Rating Scale

  This is to compare the 6 Item Hamilton Depression Rating Scale from the Screen to after 3 Sessions of Active or Sham LFMS (7 days post-baseline). The Hamilton Scale for Depression 6 item subscale scores range from 0-24. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.

  7 days after baseline

• Visual Analog Scale

  A Visual Analog Scale is a measurement of subjective characteristics that cannot be directly measured. Using this self questionnaire, subjects specify their level of depression along a continuous line between two end-points ranging from 0-100 (higher score means better mood).

  7 days after baseline

• Positive and Negative Affect Score (PANAS) - Negative Subscale

  The Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This negative subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).

  7 days after baseline

• Positive and Negative Affect Score (PANAS) - Positive Subscale

  The Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This positive subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).

  7 days after baseline

Study Arms (2)

Active Low Field Magnetic Stimulation

ACTIVE COMPARATOR

LFMS will follow a previously published protocol for the treatment of a Major Depressive Episode (Rohan et al. 2004). Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.

Device: Active Low Field Magnetic Stimulation

Sham Low Field Magnetic Stimulation

SHAM COMPARATOR

Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.

Device: Sham Low Field Magnetic Stimulation

Interventions

Active Low Field Magnetic Stimulation DEVICE

Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.

Active Low Field Magnetic Stimulation

Sham Low Field Magnetic Stimulation DEVICE

Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.

Sham Low Field Magnetic Stimulation

Eligibility Criteria

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

You may qualify if:

• Subjects must be able to understand and read English and give written informed consent prior to the protocol required procedures.
• Men and women, ages 18 to 65 inclusive with a diagnosis of major depressive episode as defined by DSM-IV-TR criteria.
• History of an inadequate response to 1 or more adequate antidepressant treatments in the current depressive episode.
• Subjects must have a 17-item Hamilton Rating Scale for Depression (HAM-D-17) score ≥ 18.
• Subjects must have a Body Mass Index (BMI) of approximately 18-40 kg/m².
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and must have a negative urine pregnancy test within 72 hours prior to the start of LFMS.

You may not qualify if:

• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
• Women who are pregnant or breastfeeding.
• Subjects with other DSM-IV-TR Axis I disorders other than Generalized Anxiety Disorder (GAD: 300.02), Social Anxiety Disorder (300.23), or Specific Phobia (300.29). Subjects with co-morbid GAD, Social Anxiety Disorder, or Specific Phobia are ineligible if the co-morbid condition is clinically unstable, requires treatment, or has been the primary focus of treatment within the 6 month period prior to screening.
• Delirium, dementia, or other cognitive disorder
• Schizophrenia or other psychotic disorder, based on the MINI.
• Patients with a clinically significant Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
• Patients experiencing hallucinations, delusions, or any psychotic symptomatology in the current or any previous depressive episode.
• Patients who have met DSM-IV-TR criteria for any significant substance use disorder within the past six months.
• Patients receiving new-onset psychotherapy and/or somatic therapy (light therapy, transcranial magnetic stimulation) within 6 weeks of screening, or at any time during participation in the trial.
• Patients who, in the opinion of the Investigator, are actively suicidal and at significant risk for suicide.
• Patients who have participated in any clinical trial with an investigational drug or device within the past month.
• Patients who have received ECT in the past 20 years or Vagal Nerve/Deep Brain Stimulation during their lifetime.
• Unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
• Subjects with evidence or history of significant neurological disorder, including head trauma with loss of consciousness, history of stroke, Parkinson's disease, epilepsy disorder, conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), who are taking medications to control seizures, or who have increased risk of seizures as evidenced by history of EEG with epileptiform activity (with the exception of juvenile febrile seizures).
• Patients with thyroid pathology (unless condition has been stabilized with medications for at least the past three months).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Marc Dubin, M.D.
• Organization: Weill Cornell Medical College

mrd9035@med.cornell.edu

(212) 746-5817

Study Officials

• Marc Dubin, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 17, 2018
• Results First Posted: September 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)