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

This study has been completed.
Information provided by (Responsible Party):
Moshe Isserles, Hadassah Medical Organization Identifier:
First received: April 15, 2007
Last updated: March 18, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Major Depression
Device: Transcranial Magnetic Stimulation (TMS)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • HAMILTON RATING SCALE FOR DEPRESSION 24 items [ Time Frame: 4 weeks ]

Enrollment: 57
Study Start Date: April 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep TMS stimulation Device: Transcranial Magnetic Stimulation (TMS)
Experimental: DTMS with positive cognitive-emotional provocation Device: Transcranial Magnetic Stimulation (TMS)
Experimental: DTMS with negative cognitive-emotional provocation Device: Transcranial Magnetic Stimulation (TMS)


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00460902

Beer Yaacov Medical Center
Beer Yaacov, Israel
Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Moshe Isserles, MD, MSc Hadassah Medical Organization
  More Information

Responsible Party: Moshe Isserles, MD, Hadassah Medical Organization Identifier: NCT00460902     History of Changes
Other Study ID Numbers: 395/3.11.06(HMO)
Study First Received: April 15, 2007
Last Updated: March 18, 2015

Keywords provided by Hadassah Medical Organization:
drug resistant depression

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders processed this record on May 22, 2017