Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression

NCT00920322 | Terminated Phase 4 DMC

• 2 other identifiers: NSG HREC 153UNSW HREC 9074
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Depression Rating Scales

  weekly

Study Arms (2)

five times weekly

ACTIVE COMPARATOR

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

Device: rTMS 5 x weekly

three times weekly

EXPERIMENTAL

Patients will receive rTMS three times weekly for four weeks

Device: rTMS 3 times weekly

Interventions

rTMS 5 x weekly DEVICE

Patients will receive rTMS five times weekly for 4 weeks

five times weekly

rTMS 3 times weekly DEVICE

Patients will receive rTMS 3 times weekly for 4 weeks

three times weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northside Clinic, Australia: lead

Study Sites (1)

Northside Clinic

Greenwich, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Colleen Loo, MBBS, FRANZCP, MD

  University of NSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 15, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

AU (1)