A Randomised Double-Blind Trial of Targeted Repetitive Tr... | NCT00168376

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

NCT00168376

Sponsor

The Alfred

Status

Completed

Last Update Posted

Apr 16, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Major Depressive Disorder

Interventions

Transcranial Magnetic Stimulation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2007

Last Update Posted Date

Apr 16, 2007Estimated

Description Module

Brief Summary

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

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Magnetic Stimulation	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.

Secondary Outcomes

Measure	Description	Time Frame
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).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul B Fitzgerald, MBBS, PhD	Alfred Psychiatry Research Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alfred Psychiatry Research Centre		Melbourne	Victoria	3181	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19145228	Derived	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.

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics