Major Depressive Disorder
Conditions
Keywords
Depression, MDD, Transcranial Magnetic Stimulation, Depressive Disorder, TMS
Brief summary
The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.
Interventions
DEVICECervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device
Sponsors
Cervel Neurotech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Major depressive disorder (MDD) * Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode. * Will not become pregnant during study.
Exclusion criteria
* Seizure disorder. * History of brain injury or active CNS disease. * Metal implants on or in brain, spinal cord, ear, eye or heart. * Current use of proconvulsant medications (e.g., bupropion). * Other significant psychiatric disorder. * Substance use disorder (not including caffeine or nicotine). * 7 or more failed treatment attempts for depression in one's lifetime. * Have failed to clinically remit to an adequate trial of ECT or TMS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission from depression | baseline through 4 weeks post | Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of rTMS | baseline through 4 weeks post | Determined by presence and absence of adverse events recorded daily |
Countries
Australia, United States
Outcome results
None listed