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
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