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

Major Depressive Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807105
• Other study ID #: 0013-07 SHA
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2008
• Last updated: January 4, 2012
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: January 2012
• Source: Shalvata Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• MDD patients

Exclusion Criteria:

• risk factors for convulsions

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• H-coil dTMS
treatment with deep TMS stimulation.

Locations

Country	Name	City	State
Israel	ShalvataMHC	Hod Hasharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	Brainsway

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response in HAMDS		1 YEAR	Yes