Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J van der Riet

ORCID ID

Contact details

St. Lucas Andreas Ziekenhuis
Department of Psychiatry
Jan Tooropstraat 164
Amsterdam
1016 AE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00220610

Protocol/serial number

NTR224; CCMO03.3741/SH/P03.1231L;

Study information

Scientific title

Right parietal inhibition with repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression

Acronym

TMS

Study hypothesis

Repetitive transcranial magnetic stimulation (rTMS) has a positive effect in the treatment of depression.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, double-blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

Repetitive transcranial magnetic stimulation 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. Patients were followed-up for 12 weeks after the two weeks of rTMS (follow-up period) to measure depression with different rating scales.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Depression

Secondary outcome measures

1. Changes in anxiety
2. Autonomic changes
3. Changes in the emotional attention, in the emotional memory and in the emotional recognition
4. Biochemical changes
5. Changes in the electroencephalogram (EEG)

Overall trial start date

01/05/2004

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. In- and out-patients, aged between 16 and 65 years
2. Meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for major depressive episode
3. Have a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. A history of epilepsy or any other medical disorder that should preclude the administration of rTMS. Only selective serotonin reuptake inhibitors (SSRIs), 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.
2. Antidepressive medication had to remain stable during the 14 weeks of the study
3. Schizophrenic disorder
4. A piece if metal in the brain
5. Pacemaker
6. Left-handed patients

Recruitment start date

01/05/2004

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

St. Lucas Andreas Ziekenhuis
Amsterdam
1016 AE
Netherlands

Sponsor information

Organisation

St. Lucas Andreas Hospital (Netherlands)

Sponsor details

Department of Psychiatry
Jan Tooropstraat 164
Amsterdam
1016 AE
Netherlands
f.koerselman@slaz.nl

Sponsor type

Hospital/treatment centre

Website

http://www.slaz.nl/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes