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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier:
NCT01909232
First received: July 22, 2013
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Depressive Disorder, Major
Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cervel Neurotech, Inc.:

Primary Outcome Measures:
  • Change in depression severity [ Time Frame: Baseline to four weeks (the conclusion of rTMS treatment) ] [ Designated as safety issue: No ]
    Measured by the 24-item Hamilton Rating Scale for Depression


Secondary Outcome Measures:
  • Change in depression severity [ Time Frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) ] [ Designated as safety issue: No ]
    Measured by the 24-item Hamilton Rating Scale for Depression

  • Clinically significant response [ Time Frame: Baseline to four weeks (the conclusion of rTMS treatment) ] [ Designated as safety issue: No ]
    Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score

  • Clinically significant response [ Time Frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) ] [ Designated as safety issue: No ]
    Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score

  • Remission from depression [ Time Frame: Baseline to four weeks (the conclusion of rTMS treatment) ] [ Designated as safety issue: No ]
    Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10

  • Remission from depression [ Time Frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) ] [ Designated as safety issue: No ]
    Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10

  • Change in quality of life [ Time Frame: Baseline to four weeks (the conclusion of rTMS treatment) ] [ Designated as safety issue: No ]
    Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form

  • Change in quality of life [ Time Frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) ] [ Designated as safety issue: No ]
    Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form

  • Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: July 2013
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909232

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30306
United States, Maryland
Sheppard-Pratt Health System
Baltimore, Maryland, United States, 21285
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Utah
CRI Lifetree
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Cervel Neurotech, Inc.
Investigators
Study Director: Beth Stannard, BS, CCRP, CCRC Cervel Neurotech
  More Information

Additional Information:
No publications provided

Responsible Party: Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier: NCT01909232     History of Changes
Other Study ID Numbers: CN-CFS-TRMD-2
Study First Received: July 22, 2013
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cervel Neurotech, Inc.:
Depression
Depressive Disorder
Major depression
Major depressive disorder
MDD
Treatment resistant depression
Treatment intolerant depression
TRMD
TIMD
Transcranial Magnetic Stimulation
TMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014