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Antidepressant Effect of Theta-Burst rTMS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00515658
First received: August 13, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Major Depression
 Device: theta-burst rTMS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antidepressant Effect of Theta-Burst rTMS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Study Start Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515658

Contacts
Contact: Ehud Klein, MD 972-4-8543599 e_klein@rambam.health.gov.il
Contact: Andrei Chistyakov, PhD 972-4-8543695 a_chistyakov@rambam.health.gov.il

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Ehud Klein, MD     972-4-8542559     e_klein@rambam.health.gov.il    
Contact: Andrei Chistyakov, PhD     972-4-8543695     a_chistyakov@rambam.health.gov.il    
Principal Investigator: Ehud Klein, MD            
Sub-Investigator: Andrei Chistyakov, PhD            
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ehud Klein, MD Rambam Health Care Campus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00515658     History of Changes
Other Study ID Numbers: Rambam2141_CTIL
Study First Received: August 13, 2007
Last Updated: August 13, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Major depression
Theta-burst rTMS
Cortical excitability
Hamilton depression rating scale

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013