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

NCT ID: NCT00149071

Last Updated: 2007-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Major Depression

Keywords

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Transcranial magnetic stimulation (TMS) Major depression treatment resistant major depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

rTMS

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

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

TMS

Intervention Type DEVICE

Transcraniel Magnetic Stimulation active and sham

rTMS

Intervention Type DEVICE

active Transcranial Magnetic Stimulation

rTMS

Intervention Type DEVICE

daily for three weeks

B

sham rTMS

Group Type SHAM_COMPARATOR

TMS

Intervention Type DEVICE

Transcraniel Magnetic Stimulation active and sham

rTMS

Intervention Type DEVICE

active Transcranial Magnetic Stimulation

rTMS

Intervention Type DEVICE

daily for three weeks

Interventions

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rTMS

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

Intervention Type DEVICE

TMS

Transcraniel Magnetic Stimulation active and sham

Intervention Type DEVICE

rTMS

active Transcranial Magnetic Stimulation

Intervention Type DEVICE

rTMS

daily for three weeks

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicon Valley Academy

UNKNOWN

Sponsor Role collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Line G Bretlau, MD

Role: PRINCIPAL_INVESTIGATOR

Psychiatric research Unit, Hilleroed Hospital, Denmark

Locations

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Psychiatric research unit, Hilleroed Hospital,

Hillerød, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1,2

Identifier Type: -

Identifier Source: org_study_id