Transcranial Magnetic Stimulation (rTMS) Accelerates the... | NCT00149071

Studies
Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression

NCT00149071

Sponsor

Hillerod Hospital, Denmark

Status

Completed

Last Update Posted

Nov 5, 2007Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Major Depression

Interventions

rTMS
TMS
rTMS
rTMS

Countries

Denmark

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

Nov 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

Mar 2004

Primary Completion Date

Not provided

Completion Date

Jan 2006Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 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

Nov 2, 2007

Last Update Posted Date

Nov 5, 2007Estimated

Name	Class
Medicon Valley Academy	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram in patients with prior treatment resistant depression in an acute 12 weeks trial with subsequent 24 weeks study phase with active versus placebo citalopram

Detailed Description

In this study we aimed at investigating to what degree rTMS applied over the left dorsolateral cortex relieves depressive symptoms when the treament is combined with antidepressive medication. The study will also be able to supply knowledge on how long any possible effect of the rTMS treatment lasts.

In the first 12 weeks of the trial participants are randomised to either rTMS combined with escitalopram or sham rTMS combined with escitalopram. rTMS is given daily for the first 3 weeks.

The next phase is a relapse prevention study where the responders from the initial phase are randomised to either active or placebo escitalopram for 24 weeks.

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

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	rTMS	Device: rTMS Device: TMS
B	Sham Comparator	sham rTMS	Device: TMS Device: rTMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTMS	Device	15 treatments of rTMS active with a duration of 30 minutes each	A

Measure	Description	Time Frame
depression scores		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major depression Hamilton score above 18
Age 18 to 75

Exclusion Criteria:

Pregnancy og breastfeeding
Mental retardation and organic brain disease
Alcohol and substance abuse
Metal implants in brain, pacemakers and other electronic implants

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
Line G Bretlau, MD	Psychiatric research Unit, Hilleroed Hospital, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psychiatric research unit, Hilleroed Hospital,		Hillerød		3400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided