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

This study has been completed.
Sponsor:
Collaborator:
Brainsway, Beer Yaacov Medical Center
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00460902
First received: April 15, 2007
Last updated: February 7, 2010
Last verified: January 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • HAMILTON RATING SCALE FOR DEPRESSION 24 items [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • BDI [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • CGI

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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460902

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

No publications provided

ClinicalTrials.gov Identifier: NCT00460902     History of Changes
Other Study ID Numbers: 395/3.11.06(HMO)
Study First Received: April 15, 2007
Last Updated: February 7, 2010
Health Authority: Israel: Ministry of Health, Health Technology and Infrastructure Administration, Medical Device Department

Keywords provided by Hadassah Medical Organization:
TMS
drug resistant depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014