A Randomized Sham-Controlled Study of H-Coil Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Late-Life Depression
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|ClinicalTrials.gov Identifier: NCT01760681|
Recruitment Status : Unknown
Verified June 2012 by Shalvata Mental Health Center.
Recruitment status was: Not yet recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression||Device: H- Coil DTMS Device: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2014|
Experimental: H coil DTMS
20 daily deep TMS treatments
Device: H- Coil DTMS
20 daily deep rTMS treatments
Other Name: H1 coil DTMS
Sham Comparator: inactive stimulation
20 daily sham deep TMS treatments
Other Name: inactive treatment
- Improvement in depression symptoms, evaluated by HDRS [ Time Frame: 6-8 weeks ]Clinical antidepressant response at the end of the treatment, define as a decline in Hamilton depression rating scale (HDRS-24) from the baseline rating by 50%.
- 1. Remission in depression [ Time Frame: 6-8 weeks ]1. Clinical antidepressant remission at the end of the treatment, define as exit HDRS-24 <10 and 60% reduction in total score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760681
|Contact: Yechiel Levkovich, M.Dfirstname.lastname@example.org|
|Hod Hasharon, Israel|
|Contact: Yechiel Levkovich, Prof. 972-9-7478569|