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Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring TMS, drug resistant depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed as suffering from treatment resistant major depression
  • Right laterality

Exclusion Criteria:

  • other major axis I diagnosis
  • severe axis II diagnosis
  • risk factors to convulsions
  • history of drug abuse in the past year

Sites / Locations

  • Beer Yaacov Medical Center
  • Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Deep TMS stimulation

DTMS with positive cognitive-emotional provocation

DTMS with negative cognitive-emotional provocation

Arm Description

Outcomes

Primary Outcome Measures

HAMILTON RATING SCALE FOR DEPRESSION 24 items

Secondary Outcome Measures

Full Information

First Posted
April 15, 2007
Last Updated
March 18, 2015
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00460902
Brief Title
Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication
Official Title
Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
TMS, drug resistant depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep TMS stimulation
Arm Type
Experimental
Arm Title
DTMS with positive cognitive-emotional provocation
Arm Type
Experimental
Arm Title
DTMS with negative cognitive-emotional provocation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Primary Outcome Measure Information:
Title
HAMILTON RATING SCALE FOR DEPRESSION 24 items
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed as suffering from treatment resistant major depression Right laterality Exclusion Criteria: other major axis I diagnosis severe axis II diagnosis risk factors to convulsions history of drug abuse in the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Isserles, MD, MSc
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beer Yaacov Medical Center
City
Beer Yaacov
Country
Israel
Facility Name
Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
20663568
Citation
Isserles M, Rosenberg O, Dannon P, Levkovitz Y, Kotler M, Deutsch F, Lerer B, Zangen A. Cognitive-emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcome. J Affect Disord. 2011 Feb;128(3):235-42. doi: 10.1016/j.jad.2010.06.038. Epub 2010 Jul 21.
Results Reference
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Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication

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