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
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
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
NCT ID
NCT00149071
First Posted
September 6, 2005
Last Updated
November 2, 2007
Sponsor
Hillerod Hospital, Denmark
Collaborators
Medicon Valley Academy
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
Learn more about this trial
Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression
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