Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression

Depression Clinical Trial

Official title:

A Randomised Study of rTMS in Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00920322
• Other study ID #: NSG HREC 153
• Secondary ID: UNSW HREC 9074
• Status: Terminated
• Phase: Phase 4
• First received: June 11, 2009
• Last updated: July 19, 2011
• Start date: May 2009
• Est. completion date: August 2011

Study information

• Verified date: July 2011
• Source: Northside Clinic, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• rTMS 5 x weekly
Patients will receive rTMS five times weekly for 4 weeks
• rTMS 3 times weekly
Patients will receive rTMS 3 times weekly for 4 weeks

Locations

Country	Name	City	State
Australia	Northside Clinic	Greenwich	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Northside Clinic, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Rating Scales		weekly	No