Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparative Trial of TMS Approaches to Treating Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01906905
Recruitment Status : Unknown
Verified December 2014 by Colleen Loo, The University of New South Wales.
Recruitment status was:  Recruiting
First Posted : July 24, 2013
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

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
Depression Device: Transcranial Magnetic Stimulation Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 2013
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine


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



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906905


Contacts
Layout table for location contacts
Contact: Angelo Alonzo 9382 3720 TMSandDCS@unsw.edu.au

Locations
Layout table for location information
Australia, New South Wales
Black Dog Institute, University of New South Wales Recruiting
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
The University of New South Wales
Investigators
Layout table for investigator information
Principal Investigator: Colleen Loo, MB.BS. (Hons), FRANZCP, MD. Black Dog Institute, University of New South Wales

Publications of Results:

Other Publications:
Layout table for additonal information
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: July 24, 2013    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders