A Comparative Trial of TMS Approaches to Treating Depression

March 29, 2023 updated by: Colleen Loo, The University of New South Wales
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2052
        • Black Dog Institute, University of New South Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcranial Magnetic Stimulation
Active TMS (1)
Device: Transcranial Magnetic Stimulation
Active Comparator: Transcranial Magnetic Stimulation 2
Active TMS (2)
Device: Transcranial Magnetic Stimulation
Active Comparator: Transcranial Magnetic Stimulation 3
Active TMS (3)
Device: Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Åsberg Depression Rating Scale(MADRS)
Time Frame: Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.
Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Investigators

  • Principal Investigator: Colleen Loo, MB.BS. (Hons), FRANZCP, MD., Black Dog Institute, University of New South Wales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

July 21, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC13053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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