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

March 18, 2015 updated by: Moshe Isserles, Hadassah Medical Organization

Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HAMILTON RATING SCALE FOR DEPRESSION 24 items
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 15, 2007

First Submitted That Met QC Criteria

April 15, 2007

First Posted (Estimate)

April 17, 2007

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 395/3.11.06(HMO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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