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A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder

NCT ID: NCT00168376

Last Updated: 2007-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-04-30

Brief Summary

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The study will involve a 3-week (15 session) randomized double-blind clinical trial of two repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment resistant depression. rTMS site selection will be localized from structural MRI scans.

The patients will be randomized to one of two conditions

1. rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,
2. rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral prefrontal cortex targeted control).

Detailed Description

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The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis. At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of less than or equal to 10.

Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale). A cognitive battery is also administered.

Inclusion Criteria:

* Moderate to severe depressive symptoms as indicated as MADRS \>20
* Failure to respond to a minimum of two antidepressant medications
* No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial Exclusion Criteria
* Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
* Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
* In the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy
* Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

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Transcranial Magnetic Stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe depressive symptoms as indicated as MADRS \>20
* Failure to respond to a minimum of two antidepressant medications
* No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial

Exclusion Criteria

* Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
* Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
* In the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy
* Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Alfred

OTHER

Sponsor Role lead

Principal Investigators

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Paul B Fitzgerald, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Alfred Psychiatry Research Centre

Locations

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Alfred Psychiatry Research Centre

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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Fitzgerald PB, Hoy K, McQueen S, Maller JJ, Herring S, Segrave R, Bailey M, Been G, Kulkarni J, Daskalakis ZJ. A randomized trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression. Neuropsychopharmacology. 2009 Apr;34(5):1255-62. doi: 10.1038/npp.2008.233. Epub 2009 Jan 14.

Reference Type DERIVED
PMID: 19145228 (View on PubMed)

Other Identifiers

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57/04

Identifier Type: -

Identifier Source: org_study_id