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

This study has been completed.
Sponsor:
Collaborator:
Brainsway
Information provided by:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00445237
First received: March 7, 2007
Last updated: February 4, 2009
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Major Depression
Device: H1 and H2 deep TMS coils
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the H1 Coil and H2 Coil TMS Device - Safety and Feasibility in Major Depression Episode

Further study details as provided by Shalvata Mental Health Center:

Study Start Date: May 2006
Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445237

Locations
Israel
Shalvata MHC
Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Brainsway
Investigators
Principal Investigator: Hilik Levkovits Day care hospital director
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00445237     History of Changes
Other Study ID Numbers: SH-505
Study First Received: March 7, 2007
Last Updated: February 4, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
major depression
TMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014