Back to resultsA Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression, Depressive Disorder, Major depression, Major depressive disorder, MDD, Treatment resistant depression, Treatment intolerant depression, TRMD, TIMD, Transcranial Magnetic Stimulation, TMS
Eligibility 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
Sites / Locations
- Emory University
- Sheppard-Pratt Health System
- Dartmouth-Hitchcock Medical Center
- Kaiser Permanente Center for Health Research
- Butler Hospital
- CRI Lifetree
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active rTMS treatment
Sham rTMS treatment
Arm Description
Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Outcomes
Primary Outcome Measures
Change in depression severity
Measured by the 24-item Hamilton Rating Scale for Depression
Secondary Outcome Measures
Change in depression severity
Measured by the 24-item Hamilton Rating Scale for Depression
Clinically significant response
Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score
Clinically significant response
Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score
Remission from depression
Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10
Remission from depression
Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10
Change in quality of life
Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form
Change in quality of life
Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form
Incidence of treatment-emergent adverse events and serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01909232
Brief Title
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cervel Neurotech, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depression, Depressive Disorder, Major depression, Major depressive disorder, MDD, Treatment resistant depression, Treatment intolerant depression, TRMD, TIMD, Transcranial Magnetic Stimulation, TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active rTMS treatment
Arm Type
Experimental
Arm Description
Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Arm Title
Sham rTMS treatment
Arm Type
Sham Comparator
Arm Description
Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Intervention Type
Device
Intervention Name(s)
Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depression severity
Description
Measured by the 24-item Hamilton Rating Scale for Depression
Time Frame
Baseline to four weeks (the conclusion of rTMS treatment)
Secondary Outcome Measure Information:
Title
Change in depression severity
Description
Measured by the 24-item Hamilton Rating Scale for Depression
Time Frame
Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Title
Clinically significant response
Description
Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score
Time Frame
Baseline to four weeks (the conclusion of rTMS treatment)
Title
Clinically significant response
Description
Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score
Time Frame
Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Title
Remission from depression
Description
Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10
Time Frame
Baseline to four weeks (the conclusion of rTMS treatment)
Title
Remission from depression
Description
Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10
Time Frame
Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Title
Change in quality of life
Description
Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form
Time Frame
Baseline to four weeks (the conclusion of rTMS treatment)
Title
Change in quality of life
Description
Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form
Time Frame
Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Title
Incidence of treatment-emergent adverse events and serious adverse events
Time Frame
Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Stannard, BS, CCRP, CCRC
Organizational Affiliation
Cervel Neurotech
Official's Role
Study Director
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Sheppard-Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
CRI Lifetree
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.cervel.com
Description
Sponsor Website
Learn more about this trial
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
We'll reach out to this number within 24 hrs