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Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression

Primary Purpose

Depression

Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
rTMS 5 x weekly
rTMS 3 times weekly
Sponsored by
Northside Clinic, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Transcranial Magnetic Stimulation

Eligibility Criteria

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

Inclusion Criteria:

  • Aged >/= 18
  • DSM-IV diagnosis of Major Depressive Episode (bipolar or MDD)
  • MADRS score >/= 20
  • Able to give informed consent
  • Psychoactive medication dosages have been stable for a period of 4 weeks prior to entry in the study

Exclusion Criteria:

  • Co-morbid alcohol or drug abuse or dependence (last 3 months), current eating disorder, mental retardation, schizophrenia, rapid cycling bipolar
  • A history of mood 'switching' in response to other treatments, which cannot be contained by concurrent treatment, e.g., mood stabiliser
  • Pregnancy
  • Significant neurological disorder that increases seizure risk
  • Metal objects in the head, pacemakers, or a history of epilepsy
  • Patients who have failed to respond to a course of ECT in their current episode of depression
  • A high risk of suicide

Sites / Locations

  • Northside Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

five times weekly

three times weekly

Arm Description

Patients will receive rTMS on each weekday for 4 weeks (5 x weekly)

Patients will receive rTMS three times weekly for four weeks

Outcomes

Primary Outcome Measures

Depression Rating Scales

Secondary Outcome Measures

Full Information

First Posted
June 11, 2009
Last Updated
July 19, 2011
Sponsor
Northside Clinic, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00920322
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression
Official Title
A Randomised Study of rTMS in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Technical issues impeded recruitment.
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Northside Clinic, Australia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will report on the outcomes of rTMS administered 3 times per week, compared with the standard protocol of 5 times per week. Participants will be randomly assigned to frequency condition and depressive symptomatology will be measured weekly using a range of clinician and self-rated questionnaires. Participants will remain in the study for at least 4 weeks, with the option of continuing for a further 2 weeks as judged by the study psychiatrist. It is hypothesised that rTMS administered three times per week will be equally as effective as rTMS administered five times per week in reducing depressive symptomatology.
Detailed Description
Numerous studies have demonstrated the efficacy of active rTMS over sham rTMS for depression; however, few have systematically studied the optimal frequency of treatment sessions to achieve this efficacy. To date, the majority of studies have administered rTMS every weekday, although this approach has not been widely contested. In addition, most studies have only assessed the effectiveness of rTMS over a two week period, which has resulted in some improvement in depressive symptomatology; however, a longer treatment course would likely result in greater improvement. In this study depressed patients will be randomly assigned to receive rTMS either 3 or 5 times per week, for a period of 4-6 weeks. A range of rating scales will be used to assess the improvement of depressive symptomatology within and between the two frequency groups, to ultimately determine whether TMS is needed 5 times per week to achieve adequate anti-depressant effects or whether 3 times per week is sufficient in achieving a similar level of efficacy for patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
five times weekly
Arm Type
Active Comparator
Arm Description
Patients will receive rTMS on each weekday for 4 weeks (5 x weekly)
Arm Title
three times weekly
Arm Type
Experimental
Arm Description
Patients will receive rTMS three times weekly for four weeks
Intervention Type
Device
Intervention Name(s)
rTMS 5 x weekly
Intervention Description
Patients will receive rTMS five times weekly for 4 weeks
Intervention Type
Device
Intervention Name(s)
rTMS 3 times weekly
Intervention Description
Patients will receive rTMS 3 times weekly for 4 weeks
Primary Outcome Measure Information:
Title
Depression Rating Scales
Time Frame
weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged >/= 18 DSM-IV diagnosis of Major Depressive Episode (bipolar or MDD) MADRS score >/= 20 Able to give informed consent Psychoactive medication dosages have been stable for a period of 4 weeks prior to entry in the study Exclusion Criteria: Co-morbid alcohol or drug abuse or dependence (last 3 months), current eating disorder, mental retardation, schizophrenia, rapid cycling bipolar A history of mood 'switching' in response to other treatments, which cannot be contained by concurrent treatment, e.g., mood stabiliser Pregnancy Significant neurological disorder that increases seizure risk Metal objects in the head, pacemakers, or a history of epilepsy Patients who have failed to respond to a course of ECT in their current episode of depression A high risk of suicide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Loo, MBBS, FRANZCP, MD
Organizational Affiliation
University of NSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northside Clinic
City
Greenwich
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia

12. IPD Sharing Statement

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Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression

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