Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT01860157
Brief Summary:
In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left DLPFC. The investigators propose that active stimulation with the H1 coil will result in higher remission rates than placebo stimulation but will have a similar tolerability and safety profile.
Detailed Description:
This study is a randomized double blind, sham controlled study to evaluate the safety and efficacy of H1-coil rTMS as a treatment for patients over 60 years of age with major depressive disorder who have not tolerated or failed to respond to antidepressant medications. The study duration is 4-6 weeks in length. The acute phase is 4 weeks of 5 daily treatments followed by 2 weeks of biweekly treatment if remission is achieved at the 4 week mark. Symptom change and remission criteria will be assessed using the HRDS-24 item. Cognition will be assessed using a validated battery.
Study:
NCT01860157
Study Brief:
Protocol Section:
NCT01860157