search
Back to results

Antidepressant Effect of Theta-Burst rTMS

Primary Purpose

Major Depression

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
theta-burst rTMS
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major depression, Theta-burst rTMS, Cortical excitability, Hamilton depression rating scale

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Rambam Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 13, 2007
Last Updated
August 13, 2007
Sponsor
Rambam Health Care Campus
search

1. Study Identification

Unique Protocol Identification Number
NCT00515658
Brief Title
Antidepressant Effect of Theta-Burst rTMS
Official Title
Antidepressant Effect of Theta-Burst rTMS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major depression, Theta-burst rTMS, Cortical excitability, Hamilton depression rating scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
theta-burst rTMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehud Klein, MD
Phone
972-4-8543599
Email
e_klein@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Andrei Chistyakov, PhD
Phone
972-4-8543695
Email
a_chistyakov@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehud Klein, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehud Klein, MD
Phone
972-4-8542559
Email
e_klein@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Andrei Chistyakov, PhD
Phone
972-4-8543695
Email
a_chistyakov@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ehud Klein, MD
First Name & Middle Initial & Last Name & Degree
Andrei Chistyakov, PhD

12. IPD Sharing Statement

Learn more about this trial

Antidepressant Effect of Theta-Burst rTMS

We'll reach out to this number within 24 hrs