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 is currently recruiting participants.

Verified by Shalvata Mental Health Center, November 2008

First Received: November 20, 2008 Last Updated: March 18, 2009 History of Changes

Sponsors and Collaborators:	Shalvata Mental Health Center Brainsway
Information provided by:	Shalvata Mental Health Center
ClinicalTrials.gov Identifier:	NCT00807105

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 tms Device: h-COIL tms Device: h-COIL TMS	Phase II

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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 ]

Estimated Enrollment:	12
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

DEEP TMS DEVICE

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

Contacts

Contact: Eiran Harel

097478644

evharel@clalit.org.il

Locations

Israel
ShalvataMHC	Recruiting
Hod Hasharon, Israel
Contact: Eiran 097478644 evharel@clalit.org.il
SHALVATAMHC	Recruiting
HOD HASHARON, Israel
Contact: EIRAN 097478644 EVHAREL@CLALIT.ORG.IL

Sponsors and Collaborators

Shalvata Mental Health Center

Brainsway

More Information

No publications provided

Responsible Party:	shalvataMHC ( E Harel )
Study ID Numbers:	0013-07 SHA
Study First Received:	November 20, 2008
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00807105 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:

MOOD EVALUATION

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 06, 2009