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

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
rTMS
TMS
rTMS
rTMS
Sponsored by
Hillerod Hospital, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Transcranial magnetic stimulation (TMS), Major depression, treatment resistant major depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric research unit, Hilleroed Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

A

B

Arm Description

rTMS

sham rTMS

Outcomes

Primary Outcome Measures

depression scores

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
November 2, 2007
Sponsor
Hillerod Hospital, Denmark
Collaborators
Medicon Valley Academy
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1. Study Identification

Unique Protocol Identification Number
NCT00149071
Brief Title
Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression
Official Title
Treatment of Therapy-Resistant Major Depression With Transcranial Stimulation rTMS in Combination With Escitalopram
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hillerod Hospital, Denmark
Collaborators
Medicon Valley Academy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Transcranial magnetic stimulation (TMS), Major depression, treatment resistant major depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
rTMS
Arm Title
B
Arm Type
Sham Comparator
Arm Description
sham rTMS
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
15 treatments of rTMS active with a duration of 30 minutes each
Intervention Type
Device
Intervention Name(s)
TMS
Intervention Description
Transcraniel Magnetic Stimulation active and sham
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
active Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
daily for three weeks
Primary Outcome Measure Information:
Title
depression scores
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line G Bretlau, MD
Organizational Affiliation
Psychiatric research Unit, Hilleroed Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric research unit, Hilleroed Hospital,
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

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

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