REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION

September 13, 2005 updated by: St. Lucas Andreas Ziekenhuis Hospital

Right Parietal Inhibition With rTMS in the Treatment of Depression

Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex.

We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales.

We hypothesized that rTMS has a positive effect in the treatment of depression

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1061 AE
        • Recruiting
        • st. Lucas Andreas Ziekenhuis/ Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included

Exclusion Criteria:

  • A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study.

Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5)
Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)

Secondary Outcome Measures

Outcome Measure
-Changes in anxiety
-.Autonomic changes
-.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
-.Biochemical changes
-.Changes in the EEG
>> measured before tms and after (at T=0 and T=2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Lucas Andreas Ziekenhuis Hospital

Investigators

  • Study Director: G.F Koerselman, prof. dr., st Lucas Andreas Ziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2005

Last Update Submitted That Met QC Criteria

September 13, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCMO03.3741/SH/P03.1231L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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