A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)

A Prospective, Double-Blind, Randomized, Parallel-Group, Sham-Controlled Feasibility Trial of Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder

The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator; Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30306
      • Emory University
  • Maryland
    • Baltimore, Maryland, United States, 21285
      • Sheppard-Pratt Health System
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • CRI Lifetree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current major depressive disorder (MDD)
• Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
• On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
• Weight less than 350 pounds

Exclusion Criteria:

• Current major depressive disorder episode of more than three years
• Seizure disorder
• History of brain injury, stroke or active central nervous system disease
• Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
• Active suicidal intent or plan
• Other significant psychiatric disorder
• Alcohol or substance dependence or abuse
• Prior treatment with transcranial magnetic stimulation
• Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation
• If female, pregnant or lactating or planning to become pregnant within the next three months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active rTMS treatment; Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator	Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator; The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.
Sham Comparator: Sham rTMS treatment; Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator	Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator; The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression severity	Measured by the 24-item Hamilton Rating Scale for Depression	Baseline to four weeks (the conclusion of rTMS treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression severity	Measured by the 24-item Hamilton Rating Scale for Depression	Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Clinically significant response	Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score	Baseline to four weeks (the conclusion of rTMS treatment)
Clinically significant response	Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score	Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Remission from depression	Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10	Baseline to four weeks (the conclusion of rTMS treatment)
Remission from depression	Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10	Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Change in quality of life	Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form	Baseline to four weeks (the conclusion of rTMS treatment)
Change in quality of life	Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form	Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Incidence of treatment-emergent adverse events and serious adverse events		Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)

Collaborators and Investigators

• Sponsor: Cervel Neurotech, Inc.
• Investigators: Study Director: Beth Stannard, BS, CCRP, CCRC, Cervel Neurotech

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Depressive Disorder; MDD; Transcranial Magnetic Stimulation; Major depression; TMS; Treatment resistant depression; Major depressive disorder; Treatment intolerant depression; TRMD; TIMD
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: CN-CFS-TRMD-2