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Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression

A Randomised Study of rTMS in Depression

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00920322
Enrollment
40
Registered
2009-06-15
Start date
2009-05-31
Completion date
2011-08-31
Last updated
2011-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Transcranial Magnetic Stimulation

Brief 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.

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.

Interventions

DEVICErTMS 5 x weekly

Patients will receive rTMS five times weekly for 4 weeks

DEVICErTMS 3 times weekly

Patients will receive rTMS 3 times weekly for 4 weeks

Sponsors

Northside Clinic, Australia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Depression Rating Scalesweekly

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026