Clinical trial NCT01909232: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Cervel Neurotech, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in depression severity
timeFrame: Baseline to four weeks (the conclusion of rTMS treatment)
Secondary outcomes:
measure: Change in depression severity
timeFrame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
measure: Clinically significant response
timeFrame: Baseline to four weeks (the conclusion of rTMS treatment)
measure: Clinically significant response
timeFrame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
measure: Remission from depression
timeFrame: Baseline to four weeks (the conclusion of rTMS treatment)
measure: Remission from depression
timeFrame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
measure: Change in quality of life
timeFrame: Baseline to four weeks (the conclusion of rTMS treatment)
measure: Change in quality of life
timeFrame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
measure: Incidence of treatment-emergent adverse events and serious adverse events
timeFrame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: Sheppard-Pratt Health System
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Salt Lake City
country: United States
facility: CRI Lifetree
state: Utah
Study officials:
affiliation: Cervel Neurotech
name: Beth Stannard, BS, CCRP, CCRC
role: STUDY_DIRECTOR
References: