Depressive Disorder, Major
Conditions
Keywords
Depression, Depressive Disorder, Major depression, Major depressive disorder, MDD, Treatment resistant depression, Treatment intolerant depression, TRMD, TIMD, Transcranial Magnetic Stimulation, TMS
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.
Interventions
DEVICEActive 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.
DEVICEInactive 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.
Sponsors
Cervel Neurotech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression severity | Baseline to four weeks (the conclusion of rTMS treatment) | Measured by the 24-item Hamilton Rating Scale for Depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression severity | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) | Measured by the 24-item Hamilton Rating Scale for Depression |
| Clinically significant response | Baseline to four weeks (the conclusion of rTMS treatment) | Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score |
| Remission from depression | Baseline to four weeks (the conclusion of rTMS treatment) | Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10 |
| Change in quality of life | Baseline to four weeks (the conclusion of rTMS treatment) | Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form |
| Incidence of treatment-emergent adverse events and serious adverse events | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) | — |
Countries
United States
Outcome results
None listed