Repetitive transcranial magnetic stimulation in the treatment of depression
| ISRCTN | ISRCTN13548185 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13548185 |
| ClinicalTrials.gov (NCT) | NCT00220610 |
| Protocol serial number | NTR224; CCMO03.3741/SH/P03.1231L; |
| Sponsor | St. Lucas Andreas Hospital (Netherlands) |
| Funder | Not provided at time of registration |
- 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
Scientific
St. Lucas Andreas Ziekenhuis
Department of Psychiatry
Jan Tooropstraat 164
Amsterdam
1016 AE
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Right parietal inhibition with repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression |
| Study acronym | TMS |
| Study objectives | Repetitive 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) studied | 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 |
| Primary outcome measure(s) |
Depression |
| Key secondary outcome measure(s) |
1. Changes in anxiety |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 55 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
St. Lucas Andreas Ziekenhuis
Amsterdam
1016 AE
Netherlands
1016 AE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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
