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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:
Collaborator:
Brainsway
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00807105
First received: November 20, 2008
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • response in HAMDS [ Time Frame: 1 YEAR ] [ Designated as safety issue: Yes ]

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

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

Inclusion Criteria:

  • MDD patients

Exclusion Criteria:

  • risk factors for convulsions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807105

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

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT00807105     History of Changes
Other Study ID Numbers: 0013-07 SHA
Study First Received: November 20, 2008
Last Updated: January 4, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013