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
Information provided by:
Rambam Health Care Campus Identifier:
First received: August 13, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

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:

Further study details as provided by Rambam Health Care Campus:

Study Start Date: March 2007

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00515658

Contact: Ehud Klein, MD 972-4-8543599
Contact: Andrei Chistyakov, PhD 972-4-8543695

Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Ehud Klein, MD    972-4-8542559   
Contact: Andrei Chistyakov, PhD    972-4-8543695   
Principal Investigator: Ehud Klein, MD         
Sub-Investigator: Andrei Chistyakov, PhD         
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Ehud Klein, MD Rambam Health Care Campus
  More Information

No publications provided 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:
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses processed this record on October 09, 2015