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A Comparative Trial of TMS Approaches to Treating Depression

Primary Purpose

Depression

Status
Withdrawn
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 years.
  2. DSM-IV diagnosis of current Major Depressive Episode.
  3. MADRS score of 20 or more.
  4. Able to give informed consent.

Exclusion Criteria:

  1. DSM-IV psychotic disorder.
  2. Drug or alcohol abuse or dependence (preceding 3 months).
  3. Inadequate response to ECT (current episode of depression).
  4. Rapid clinical response required, e.g. high suicide risk.
  5. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
  6. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
  7. Pregnancy.

Sites / Locations

  • Black Dog Institute, University of New South Wales

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation 2

Transcranial Magnetic Stimulation 3

Arm Description

Active TMS (1)

Active TMS (2)

Active TMS (3)

Outcomes

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale(MADRS)

Secondary Outcome Measures

Full Information

First Posted
July 17, 2013
Last Updated
March 29, 2023
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT01906905
Brief Title
A Comparative Trial of TMS Approaches to Treating Depression
Official Title
A Comparative Trial of TMS Approaches to Treating Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Study Start Date
June 2013 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Trancranial Magnetic Stimulation (TMS) is a non-drug and non-invasive treatment for depression and has been investigated for the treatment of psychiatric illness for over 15 years. There is now established evidence indicating TMS is an effective treatment for depression. However, the effectiveness of TMS varies between people, thus requiring further research to investigate its optimal application. Investigators want to compare the effectiveness of different forms of TMS, given with differing stimulation settings to the right or left side of the brain that has been associated with depression. This could potentially help clinicians in the future to improve the prescription of TMS as a treatment for depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
Active TMS (1)
Arm Title
Transcranial Magnetic Stimulation 2
Arm Type
Active Comparator
Arm Description
Active TMS (2)
Arm Title
Transcranial Magnetic Stimulation 3
Arm Type
Active Comparator
Arm Description
Active TMS (3)
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale(MADRS)
Time Frame
Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years. DSM-IV diagnosis of current Major Depressive Episode. MADRS score of 20 or more. Able to give informed consent. Exclusion Criteria: DSM-IV psychotic disorder. Drug or alcohol abuse or dependence (preceding 3 months). Inadequate response to ECT (current episode of depression). Rapid clinical response required, e.g. high suicide risk. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device. Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Loo, MB.BS. (Hons), FRANZCP, MD.
Organizational Affiliation
Black Dog Institute, University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Dog Institute, University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16139895
Citation
Loo CK, Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disord. 2005 Nov;88(3):255-67. doi: 10.1016/j.jad.2005.08.001. Epub 2005 Sep 2.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
11922882
Citation
Sachdev PS, McBride R, Loo C, Mitchell PM, Malhi GS, Croker V. Effects of different frequencies of transcranial magnetic stimulation (TMS) on the forced swim test model of depression in rats. Biol Psychiatry. 2002 Mar 15;51(6):474-9. doi: 10.1016/s0006-3223(01)01298-7.
Results Reference
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PubMed Identifier
19530016
Citation
Slade T, Johnston A, Oakley Browne MA, Andrews G, Whiteford H. 2007 National Survey of Mental Health and Wellbeing: methods and key findings. Aust N Z J Psychiatry. 2009 Jul;43(7):594-605. doi: 10.1080/00048670902970882.
Results Reference
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PubMed Identifier
20439832
Citation
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Results Reference
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PubMed Identifier
17880752
Citation
Loo CK, McFarquhar TF, Mitchell PB. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Int J Neuropsychopharmacol. 2008 Feb;11(1):131-47. doi: 10.1017/S1461145707007717. Epub 2007 Sep 20.
Results Reference
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PubMed Identifier
10074879
Citation
Nahas Z, Bohning DE, Molloy MA, Oustz JA, Risch SC, George MS. Safety and feasibility of repetitive transcranial magnetic stimulation in the treatment of anxious depression in pregnancy: a case report. J Clin Psychiatry. 1999 Jan;60(1):50-2. doi: 10.4088/jcp.v60n0111.
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PubMed Identifier
17573044
Citation
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Citation
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Citation
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A Comparative Trial of TMS Approaches to Treating Depression

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