NCT00460902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2007

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

April 15, 2007

Last Update Submit

March 18, 2015

Conditions

Major Depression

Keywords

TMSdrug resistant depression

Outcome Measures

Primary Outcomes (1)

  • HAMILTON RATING SCALE FOR DEPRESSION 24 items

    4 weeks

Study Arms (3)

Deep TMS stimulation

EXPERIMENTAL
Device: Transcranial Magnetic Stimulation (TMS)

DTMS with positive cognitive-emotional provocation

EXPERIMENTAL
Device: Transcranial Magnetic Stimulation (TMS)

DTMS with negative cognitive-emotional provocation

EXPERIMENTAL
Device: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS)DEVICE
DTMS with negative cognitive-emotional provocationDTMS with positive cognitive-emotional provocationDeep TMS stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beer Yaacov Medical Center

Beer Yaacov, Israel

Location

Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization

Jerusalem, Israel

Location

Related Publications (1)

  • 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.

    PMID: 20663568BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Moshe Isserles, MD, MSc

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 15, 2007

First Posted

April 17, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

IL(2)