Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode

This study has been completed.
Sponsor:
Collaborator:
Brainsway
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00807105
First received: November 20, 2008
Last updated: January 4, 2012
Last verified: January 2012

November 20, 2008
January 4, 2012
June 2008
May 2010   (final data collection date for primary outcome measure)
response in HAMDS [ Time Frame: 1 YEAR ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00807105 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode
Not Provided

This is a prospective open label study of acute and maintenance treatment of MDD. The acute phase consists of daily treatments for 4 weeks. maintenance will be twice a week for eight weeks followed by 10 weeks of once a week treatments.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Device: H-coil dTMS
treatment with deep TMS stimulation.
Experimental: depressive patients
patients suffering from deppresion
Intervention: Device: H-coil dTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • MDD patients

Exclusion Criteria:

  • risk factors for convulsions
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00807105
0013-07 SHA
Yes
Shalvata Mental Health Center
Shalvata Mental Health Center
Brainsway
Not Provided
Shalvata Mental Health Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP