Back to resultsEvaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
H-coil dTMS
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring MOOD EVALUATION
Eligibility Criteria
Inclusion Criteria:
- MDD patients
Exclusion Criteria:
- risk factors for convulsions
Sites / Locations
- ShalvataMHC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
depressive patients
Arm Description
patients suffering from deppresion
Outcomes
Primary Outcome Measures
response in HAMDS
Secondary Outcome Measures
Full Information
NCT ID
NCT00807105
First Posted
November 20, 2008
Last Updated
January 4, 2012
Sponsor
Shalvata Mental Health Center
Collaborators
Brainsway
1. Study Identification
Unique Protocol Identification Number
NCT00807105
Brief Title
Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center
Collaborators
Brainsway
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MOOD EVALUATION
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
depressive patients
Arm Type
Experimental
Arm Description
patients suffering from deppresion
Intervention Type
Device
Intervention Name(s)
H-coil dTMS
Intervention Description
treatment with deep TMS stimulation.
Primary Outcome Measure Information:
Title
response in HAMDS
Time Frame
1 YEAR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MDD patients
Exclusion Criteria:
risk factors for convulsions
Facility Information:
Facility Name
ShalvataMHC
City
Hod Hasharon
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode
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