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
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Transcranial Magnetic Stimulation
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
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
NCT ID
NCT00920322
First Posted
June 11, 2009
Last Updated
July 19, 2011
Sponsor
Northside Clinic, Australia
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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