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

Hillerod Hospital, Denmark

Status: Completed

Conditions: Major Depression

Treatments: Device: rTMS; Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT00149071

1,2

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

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61 participants in 2 patient groups

A

Active Comparator group

Description:

rTMS

Treatment:

Device: TMS

Device: rTMS

B

Sham Comparator group

Description:

sham rTMS

Treatment:

Device: TMS

Device: rTMS