Repetitive transcranial magnetic stimulation in the treatment of depression

ISRCTN ISRCTN13548185
DOI https://doi.org/10.1186/ISRCTN13548185
ClinicalTrials.gov number NCT00220610
Secondary identifying numbers NTR224; CCMO03.3741/SH/P03.1231L;
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
31/12/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J van der Riet
Scientific

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

Study information

Study designRandomised, double-blind, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRight parietal inhibition with repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression
Study acronymTMS
Study objectivesRepetitive transcranial magnetic stimulation (rTMS) has a positive effect in the treatment of depression.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedDepression
InterventionRepetitive 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 typeOther
Primary outcome measureDepression
Secondary outcome measures1. 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 study start date01/05/2004
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Total final enrolment55
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/05/2004
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

St. Lucas Andreas Ziekenhuis
Amsterdam
1016 AE
Netherlands

Sponsor information

St. Lucas Andreas Hospital (Netherlands)
Hospital/treatment centre

Department of Psychiatry
Jan Tooropstraat 164
Amsterdam
1016 AE
Netherlands

Email f.koerselman@slaz.nl
Website http://www.slaz.nl/
ROR logo "ROR" https://ror.org/016jc2h42

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/10/2004 31/12/2021 Yes No

Editorial Notes

31/12/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
28/01/2019: No publication found, verifying results status with the principal investigator