Depression Mental and Behavioural Disorders Depression
Conditions
Interventions
Patients were randomly assigned to one of two groups using block randomisation. Both investigators and patients are blinded (double blind study)
the physicians and nurses who treat the patients are not blinded.
Intervention group: Participants receive 20 rTMS sessions (10Hz stimulation of left DLPFC) over a period of 4 weeks.
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females above 18 years of age 2. Unipolar major depressive disorder without psychotic symptoms (DSM-lV), with a chronic course during the last two years 3. Treatment resistance for at least two antidepressants treatment and a form of psychotherapy
Exclusion criteria
Exclusion criteria: 1. Presence of a current or past relevant somatic or neurological disorder 2. A comorbid diagnosis of bipolar disorder, schizophrenia or substance dependence disorders 3. Epilepsy, convulsion or seizure (TMS) 4. Serious head trauma or brain surgery 5. Large or ferromagnetic metal parts in the head (except for a dental wire) 6. lmplanted cardiac pacemaker or neurostimulator 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms are measured using the Hamilton Depression Rating Scale at baseline and one week after treatment end. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response as defined as a =50% decrease of the HDRS score between baseline and one week after treatment end 2. Remission, as defined as a HDRS score =7, is assessed one week after the last rTMS treatment 3. Side-effects are assessed using a side-effect questionnaire at baseline and one week after treatment end 4. Neurobiological changes related to rTMS treatment are measured using a combined EEG/FMRI longitudinal set-up at baseline and one week after treatment end | — |
Countries
Netherlands
Outcome results
None listed