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Antidepressant Effect of Theta-Burst rTMS

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ClinicalTrials.gov Identifier: NCT00515658
Recruitment Status : Unknown
Verified August 2007 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : August 14, 2007
Last Update Posted : August 14, 2007
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Major Depression Device: theta-burst rTMS Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antidepressant Effect of Theta-Burst rTMS
Study Start Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00515658     History of Changes
Other Study ID Numbers: Rambam2141_CTIL
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: August 14, 2007
Last Verified: August 2007

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, Major
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs