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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807105
First Posted: December 11, 2008
Last Update Posted: January 5, 2012
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 (Responsible Party):
Shalvata Mental Health Center
  Purpose
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 Intervention Phase
Major Depressive Disorder Device: H-coil dTMS Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Shalvata Mental Health Center:

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

Enrollment: 29
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: depressive patients
patients suffering from deppresion
Device: H-coil dTMS
treatment with deep TMS stimulation.

  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:

  • MDD patients

Exclusion Criteria:

  • risk factors for convulsions
  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): NCT00807105


Locations
Israel
ShalvataMHC
Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Brainsway
  More Information

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT00807105     History of Changes
Other Study ID Numbers: 0013-07 SHA
First Submitted: November 20, 2008
First Posted: December 11, 2008
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Shalvata Mental Health Center:
MOOD EVALUATION

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


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