A Comparative Trial of TMS Approaches to Treating Depression

Sponsor
The University of New South Wales (Other)
Overall Status
Unknown status
CT.gov ID
NCT01906905
Collaborator
(none)
1
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparative Trial of TMS Approaches to Treating Depression
Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Jul 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Montgomery-Åsberg Depression Rating Scale(MADRS) [Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Black Dog Institute, University of New South Wales Sydney New South Wales Australia 2052

Sponsors and Collaborators

  • The University of New South Wales

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Colleen Loo, Professor Colleen Loo, Black Dog Institute, The Prince of Wales Hospital, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01906905
Other Study ID Numbers:
  • HC13053
First Posted:
Jul 24, 2013
Last Update Posted:
Dec 4, 2014
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2014