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

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: NCT00807105
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
Shalvata Mental Health Center

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: H-coil dTMS Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: depressive patients
patients suffering from deppresion
Device: H-coil dTMS
treatment with deep TMS stimulation.

Primary Outcome Measures :
  1. response in HAMDS [ Time Frame: 1 YEAR ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • MDD patients

Exclusion Criteria:

  • risk factors for convulsions

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): NCT00807105

Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center

Responsible Party: Shalvata Mental Health Center Identifier: NCT00807105     History of Changes
Other Study ID Numbers: 0013-07 SHA
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Shalvata Mental Health Center:

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