NCT00927173

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
233

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
5 countries

22 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

First Submitted

Initial submission to the registry

June 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 15, 2020

Status Verified

February 1, 2013

Enrollment Period

2.5 years

First QC Date

June 23, 2009

Last Update Submit

July 13, 2020

Conditions

Major Depressive Disorder

Keywords

TMSTranscranial Magnetic StimulationMDDMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • HDRS-21

    5 weeks

Secondary Outcomes (3)

  • Response rate

    5 weeks

  • Remission rates

    5 weeks

  • Quality of Life

    5 weeks

Study Arms (2)

Sham

SHAM COMPARATOR

Sham treatment

Device: Brainsway H-Coil Deep TMS System (Sham treatment)

Active

ACTIVE COMPARATOR

Active Deep Transcranial Magnetic Stimulation treatment

Device: Brainsway H-Coil Deep TMS System

Interventions

Brainsway H-Coil Deep TMS SystemDEVICE

Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions

Active
Brainsway H-Coil Deep TMS System (Sham treatment)DEVICE

In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.

Sham

Eligibility Criteria

Age22 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients.
  • Men and women 22-68 years of age.
  • Primary DSM-IV diagnosis of Major Depression, single or recurrent episode.
  • Current depressive episode is less than 5 years duration.
  • The patient did not respond to at least one but not more than four antidepressant treatments in the current episode.
  • Patients who have not completed antidepressant trials due to intolerance to therapy of 2 or more anti-depressant medications in the current episode.
  • Satisfactory safety screening questionnaire for transcranial magnetic stimulation.
  • Patients not suffering from hypo or hyper-thyroidism based on pre-study TSH level or medically stabilized.
  • Patients able to tolerate psychotropic medication washout and no psychotropics during the treatment, other than benzodiazepine at equivalent daily dose of up to 3 mg lorazepam.

You may not qualify if:

  • A history of schizophrenia, any psychotic disorder, PTSD, bipolar disorder, OCD, eating disorders (e.g., anorexia nervosa, bulimia) or substance abuse
  • A history of panic disorder, social anxiety disorder or personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
  • A history of any significant medical disease (i.e., cardiovascular, gastrointestinal, etc.)
  • A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
  • Undergone rTMS treatment, Vagus Nerve Stimulation, or Deep Brain Stimulation.
  • Received ECT within the last 3 months or failed to respond to ECT treatment.
  • Individuals with a significant neurological disorder or insult including:
  • Any condition likely to be associated with increased intracranial pressure
  • Space occupying brain lesion
  • Any history of seizure EXCEPT those therapeutically induced by ECT
  • History of cerebrovascular accident
  • Transient ischemic attack within two years
  • Cerebral aneurysm
  • Dementia
  • Parkinson's disease
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

University of California (UCLA)

Los Angeles, California, 90095, United States

Location

UC Davis Center for Mind & Brain

Sacramento and Davis, California, 95817, United States

Location

Smart Brain and Health

Santa Monica, California, 90403, United States

Location

Advanced Mental Health Care Inc. - Juno Beach

Juno Beach, Florida, 33408, United States

Location

Advanced Mental Health Care Inc. - Royal Palm Beach

Royal Palm Beach, Florida, 33411, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

McLean Hospital - TMS Services

Belmont, Massachusetts, 02478, United States

Location

Greater Nashua Mental Health Center

Nashua, New Hampshire, 03060, United States

Location

Neuropharmacology Services

New York, New York, 10021, United States

Location

Columbia University / New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Duke Medical Center Department of Psychiatry & Behavioral Sciences

Durham, North Carolina, 27710, United States

Location

Medical Uni. Of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8898, United States

Location

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Location

EPS Ville-Evrard

Neuilly-sur-Marne, 93332, France

Location

Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie

Bonn, Germany

Location

Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität

Munich, Germany

Location

Beer Yaacov Mental Health Center

Beer Yaacov, Israel

Location

Shalvata Mental Health Center

Hod HaSharon, Israel

Location

Hadasah Ein-Karem Medical Center

Jerusalem, Israel

Location

Kfar Shaul Mental Health Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Yechiel Levkovitz, M.D

    Shalvat Mental Health Center

    PRINCIPAL INVESTIGATOR

  • Abraham Zangen, Dr.

    Weizmann Institute of Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 24, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

July 15, 2020

Record last verified: 2013-02

Locations

CA(1)FR(1)US(14)DE(2)IL(4)