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Completed

NCT Number: NCT00149071

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

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

Completed

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric research unit, Hilleroed Hospital,

Hillerød, 3400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS

Device

15 treatments of rTMS active with a duration of 30 minutes each

TMS

Device

Transcraniel Magnetic Stimulation active and sham

Primary outcomes

  1. depression scores

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Hillerod Hospital, Denmark

Other

Collaborators

  • Medicon Valley Academy

Registry information

Official study title

Treatment of Therapy-Resistant Major Depression With Transcranial Stimulation rTMS in Combination With Escitalopram

Important dates

Study start
2004
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Nov 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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