Evaluation of Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression

Major Depression Clinical Trial

Official title:

Evaluation of the H1 Coil and H2 Coil TMS Device - Safety and Feasibility in Major Depression Episode

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445237
• Other study ID #: SH-505
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2007
• Last updated: February 4, 2009
• Start date: May 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2007
• 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 study is evaluating the safety and feasibility of the novel deep TMS H-coil designs in the treatment of resistant major depression in an open study using two different H-coil designs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed as suffering from treatment resistant major depression

Exclusion Criteria:

• Other axis I diagnosis

• Risk factors for convulsions

• Electroconvulsive therapy (ECT) in the last 9 months

• History of drug abuse in the past year

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• H1 and H2 deep TMS coils

Locations

Country	Name	City	State
Israel	Shalvata MHC	Hod Hasharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	Brainsway

Country where clinical trial is conducted

Israel,