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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149071
First Posted: September 8, 2005
Last Update Posted: November 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medicon Valley Academy
Information provided by:
Hillerod Hospital, Denmark
September 6, 2005
September 8, 2005
November 5, 2007
March 2004
Not Provided
depression scores [ Time Frame: 6 weeks ]
depression scores
Complete list of historical versions of study NCT00149071 on ClinicalTrials.gov Archive Site
Not Provided
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Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression
Treatment of Therapy-Resistant Major Depression With Transcranial Stimulation rTMS in Combination With Escitalopram
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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Major Depression
  • Device: rTMS
    15 treatments of rTMS active with a duration of 30 minutes each
  • Device: TMS
    Transcraniel Magnetic Stimulation active and sham
  • Device: rTMS
    active Transcranial Magnetic Stimulation
  • Device: rTMS
    daily for three weeks
  • Active Comparator: A
    rTMS
    Interventions:
    • Device: rTMS
    • Device: TMS
    • Device: rTMS
    • Device: rTMS
  • Sham Comparator: B
    sham rTMS
    Interventions:
    • Device: TMS
    • Device: rTMS
    • Device: rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
January 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00149071
1,2
Yes
Not Provided
Not Provided
Not Provided
Hillerod Hospital, Denmark
Medicon Valley Academy
Principal Investigator: Line G Bretlau, MD Psychiatric research Unit, Hilleroed Hospital, Denmark
Hillerod Hospital, Denmark
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP