Evaluation of the Deep TMS H-Coils in the Treatment of Major Depression- Augmentation of Antidepressant Medication - Full Text View

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

This study is currently recruiting participants.
Verified by Hadassah Medical Organization, March 2007

Sponsors and Collaborators:	Hadassah Medical Organization Brainsway
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00460902

Purpose

Evaluation of the novel deep TMS H-Coil designs as an augmentation measure in the treatment of medication resistant major depression. An open study using two different H-Coil designs at two frequencies.

Condition	Intervention	Phase
Major Depression	Device: Transcranial Magnetic Stimulation (TMS)	Phase I Phase II

MedlinePlus related topics:

Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

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 21 items
BDI
CGI

Study Start Date:

April 2007

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

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

Contacts


Contact: Moshe Isserles, MD, MSc	972 54 2000797	dr.isserles@yahoo.com

Contact: Abraham Zangen, PhD	972 8 9344415

Locations


Israel
	Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization	Recruiting
	Jerusalem, Israel
	Principal Investigator: Moshe Isserles, MD, MSc

Sponsors and Collaborators

Hadassah Medical Organization

Brainsway

Investigators


Principal Investigator:	Moshe Isserles, MD, MSc	Hadassah Medical Organization

More Information

Study ID Numbers:	395/3.11.06(HMO)
First Received:	April 15, 2007
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00460902
Health Authority:	Israel: Ministry of Health, Health Technology and Infrastructure Administration, Medical Device Department

Keywords provided by Hadassah Medical Organization:

TMS

drug resistant depression

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Behavioral Symptoms

ClinicalTrials.gov processed this record on December 10, 2008