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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00445237
First Posted: March 8, 2007
Last Update Posted: February 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brainsway
Information provided by:
Shalvata Mental Health Center
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

ClinicalTrials.gov Identifier: NCT00445237     History of Changes
Other Study ID Numbers: SH-505
First Submitted: March 7, 2007
First Posted: March 8, 2007
Last Update Posted: February 5, 2009
Last Verified: March 2007

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