Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression
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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 |
- 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 |
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| Denmark | |
| Psychiatric research unit, Hilleroed Hospital, | |
| Hillerod, Denmark, 3400 | |
| 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 Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 22, 2013