Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression

NCT ID: NCT00920322

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-08-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

five times weekly

Patients will receive rTMS on each weekday for 4 weeks (5 x weekly)

Group Type: ACTIVE_COMPARATOR

rTMS 5 x weekly

Intervention Type: DEVICE

Patients will receive rTMS five times weekly for 4 weeks

three times weekly

Patients will receive rTMS three times weekly for four weeks

Group Type: EXPERIMENTAL

rTMS 3 times weekly

Intervention Type: DEVICE

Patients will receive rTMS 3 times weekly for 4 weeks

Interventions

rTMS 5 x weekly

Patients will receive rTMS five times weekly for 4 weeks

Intervention Type: DEVICE

rTMS 3 times weekly

Patients will receive rTMS 3 times weekly for 4 weeks

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northside Clinic, Australia

OTHER

Sponsor Role: lead

Responsible Party

University of NSW

Principal Investigators

Colleen Loo, MBBS, FRANZCP, MD

Role: PRINCIPAL_INVESTIGATOR

University of NSW

Locations

Northside Clinic

Greenwich, New South Wales, Australia

Countries

Australia

Other Identifiers

UNSW HREC 9074

Identifier Type: -

Identifier Source: secondary_id

NSG HREC 153

Identifier Type: -

Identifier Source: org_study_id