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

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. Identifier: NCT00445237
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : February 5, 2009
Information provided by:
Shalvata Mental Health Center

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depression Device: H1 and H2 deep TMS coils Phase 1

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : May 2006
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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 identifier (NCT number): NCT00445237

Shalvata MHC
Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Principal Investigator: Hilik Levkovits Day care hospital director Identifier: NCT00445237     History of Changes
Other Study ID Numbers: SH-505
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: March 2007

Keywords provided by Shalvata Mental Health Center:
major depression

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