Low Field Magnetic Stimulation for Treatment Resistant Depression

Completed · Not applicable · Has a placebo group

Conditions studied: Treatment Resistant Depression

In brief

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.

Key facts

Study ID

NCT01944644

Run by

Weill Medical College of Cornell University

People needed

66

Starts

2013-08-01

Expected to finish

2016-05-01

Last updated by the study team

2018-09-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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).
• Patients who have recently (within two weeks) begun any medications.
• Monoamine oxidase inhibitors (e.g., Nardil, phenelzine, Parnate, tranylcypromine, Marplan, isocarboxazide) treatment within the 2 weeks prior to enrollment.
• Patients with a history of antidepressant-induced hypomania or dysphoria.
• Participants with metal implants (Will use the NY Presbyterian Hospital MRI Checklist)
• Any of the following exclusion criteria for MRI Cardiac pacemaker or pacing wires Implanted cardioverter defibrillator (ICD) Cochlear, otologic, or other ear implant Tissue expander (e.g., breast) Implanted drug infusion device Aneurysm clip(s) Deep Brain Stimulator Other Neuro-stimulator Prosthesis (eye, penile, limb, etc.) Artificial heart valve Eyelid spring or wire Stent, filter, or coil Programmable shunt Catheter or feeding tube with metal tip Radiation seeds Medication patch (Nicotine, Nitroglycerine) Any metallic fragment, foreign body or bullets Surgical staples, clips, metallic sutures or wire mesh Bone/joint pin, screw, nail, wire, plate, etc. IUD, diaphragm, or pessary Dentures or braces Tattoo, permanent makeup or body piercing jewelry Hearing aid (Remove before entering the MR system room) Breathing problem and motion disorder Claustrophobia Hair Extensions

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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