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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909232
• Other study ID #: CN-CFS-TRMD-2
• Status: Completed
• Phase: N/A
• First received: July 22, 2013
• Last updated: July 25, 2016
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2016
• Source: Cervel Neurotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Sheppard-Pratt Health System	Baltimore	Maryland
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	Butler Hospital	Providence	Rhode Island
United States	CRI Lifetree	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Cervel Neurotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression severity	Measured by the 24-item Hamilton Rating Scale for Depression	Baseline to four weeks (the conclusion of rTMS treatment)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Incidence of treatment-emergent adverse events and serious adverse events		Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)	Yes

External Links

•   Sponsor Website
•   Study Website