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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149071
First Posted: September 8, 2005
Last Update Posted: November 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medicon Valley Academy
Information provided by:
Hillerod Hospital, Denmark
  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
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00149071     History of Changes
Other Study ID Numbers: 1,2
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: November 5, 2007
Last Verified: November 2007

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
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents