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

H

Hillerod Hospital, Denmark

Status

Completed

Conditions

Major Depression

Treatments

Device: rTMS
Device: TMS

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

61 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

61 participants in 2 patient groups

A
Active Comparator group
Description:
rTMS
Treatment:
Device: rTMS
Device: rTMS
Device: rTMS
Device: TMS
B
Sham Comparator group
Description:
sham rTMS
Treatment:
Device: rTMS
Device: rTMS
Device: rTMS
Device: TMS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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