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NCT00149071 Clinical Trial

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

Major Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00149071
Other study ID # 1,2
Secondary ID
Status Completed
Phase N/A
First received September 6, 2005
Last updated November 2, 2007
Start date March 2004
Est. completion date January 2006

Study information
Verified date November 2007
Source Hillerod Hospital, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• rTMS
15 treatments of rTMS active with a duration of 30 minutes each
• TMS
Transcraniel Magnetic Stimulation active and sham
• rTMS
active Transcranial Magnetic Stimulation
• rTMS
daily for three weeks

Locations
Country Name City State
Denmark Psychiatric research unit, Hilleroed Hospital, Hillerod

Sponsors (2)
Lead Sponsor Collaborator
Hillerod Hospital, Denmark Medicon Valley Academy

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary depression scores 6 weeks
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