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Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression

This study has been terminated.
(Technical issues impeded recruitment.)
Sponsor:
Information provided by:
Northside Clinic, Australia
ClinicalTrials.gov Identifier:
NCT00920322
First received: June 11, 2009
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Depression
Device: rTMS 5 x weekly
Device: rTMS 3 times weekly
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Study of rTMS in Depression

Further study details as provided by Northside Clinic, Australia:

Primary Outcome Measures:
  • Depression Rating Scales [ Time Frame: weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: five times weekly
Patients will receive rTMS on each weekday for 4 weeks (5 x weekly)
Device: rTMS 5 x weekly
Patients will receive rTMS five times weekly for 4 weeks
Experimental: three times weekly
Patients will receive rTMS three times weekly for four weeks
Device: rTMS 3 times weekly
Patients will receive rTMS 3 times weekly for 4 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920322

Locations
Australia, New South Wales
Northside Clinic
Greenwich, New South Wales, Australia, 2065
Sponsors and Collaborators
Northside Clinic, Australia
Investigators
Principal Investigator: Colleen Loo, MBBS, FRANZCP, MD University of NSW
  More Information

No publications provided

Responsible Party: Associate Professor Colleen Loo, University of NSW
ClinicalTrials.gov Identifier: NCT00920322     History of Changes
Other Study ID Numbers: NSG HREC 153, UNSW HREC 9074
Study First Received: June 11, 2009
Last Updated: July 19, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Northside Clinic, Australia:
Depression
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 24, 2014