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

This study has been completed.
Sponsor:
Collaborator:
Medicon Valley Academy
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT00149071
First received: September 6, 2005
Last updated: November 2, 2007
Last verified: November 2007
  Purpose

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


Condition Intervention
Major Depression
Device: rTMS
Device: TMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Therapy-Resistant Major Depression With Transcranial Stimulation rTMS in Combination With Escitalopram

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • depression scores [ Time Frame: 6 weeks ]

Enrollment: 61
Study Start Date: March 2004
Study Completion Date: January 2006
Arms Assigned Interventions
Active Comparator: A
rTMS
Device: rTMS
15 treatments of rTMS active with a duration of 30 minutes each
Device: TMS
Transcraniel Magnetic Stimulation active and sham
Device: rTMS
active Transcranial Magnetic Stimulation
Device: rTMS
daily for three weeks
Sham Comparator: B
sham rTMS
Device: TMS
Transcraniel Magnetic Stimulation active and sham
Device: rTMS
active Transcranial Magnetic Stimulation
Device: rTMS
daily for three weeks

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149071

Locations
Denmark
Psychiatric research unit, Hilleroed Hospital,
Hillerod, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Medicon Valley Academy
Investigators
Principal Investigator: Line G Bretlau, MD Psychiatric research Unit, Hilleroed Hospital, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149071     History of Changes
Other Study ID Numbers: 1,2
Study First Received: September 6, 2005
Last Updated: November 2, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hillerod Hospital, Denmark:
Transcranial magnetic stimulation (TMS)
Major depression
treatment resistant major depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014