NCT00515658

Brief Summary

The aim of this study is to evaluate the safety and efficacy of theta-burst rTMS in patients with major depression. Patients will be randomized to receive ether left-sided intermittent theta-burst rTMS or rigt-sided continuous theta-burst rTMS or sham theta-burst rTMS over two weeks period with an option for an additional two weeks period, depending on treatment response. Clinical assessments will be performed weekly by the Hamilton depression rating scale. In addition, standard neurophysiological assessment of cortical excitability will be done.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
Last Updated

August 14, 2007

Status Verified

August 1, 2007

First QC Date

August 13, 2007

Last Update Submit

August 13, 2007

Conditions

Major Depression

Keywords

Major depressionTheta-burst rTMSCortical excitabilityHamilton depression rating scale

Interventions

theta-burst rTMSDEVICE

Eligibility Criteria

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

You may qualify if:

  • Major depressive episode (DSM IV criteria).
  • Informed consent.
  • Age: 18-70.

You may not qualify if:

  • Suicidality
  • Psychosis
  • Pacemaker
  • Cardiac arrythmia
  • seizure disorder
  • implantable metal devices
  • PNS and CNS disorders
  • any other contraindications as specified in safety guidelines for rTMS (Wassermenn, 1998).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Ehud Klein, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehud Klein, MD

CONTACT

972-4-8543599e_klein@rambam.health.gov.il

Andrei Chistyakov, PhD

CONTACT

972-4-8543695a_chistyakov@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

March 1, 2007

Last Updated

August 14, 2007

Record last verified: 2007-08

Locations

IL(1)