depression
Conditions
Interventions
DBS targeted to the MFB. After the open-label phase patients are randomized to 
active DBS followed by sham DBS, or vice versa.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Primary diagnosis: Major Depressive Disorder 2) Treatment-resistance defined as inadequate response to (or intolerable side effects) of all of the following: a. At least 2 adequately dosed treatments of at least two 2nd generation antidepressants (SSRI, SNRI, NaSSA) for a period of 6-8 weeks b. An adequately dosed treatment with a tricyclic antidepressant (TCA) for 6-8 weeks c. TCA + addition of lithium when tolerable at least 6 weeks at therapeutic drug levels (>0.6 mmol/L)) d. An adequately dosed treatment with a monoamine oxidase inhibitor OR >=1 session of ECT, for which the series of ECT was terminated either due to adverse effects or insufficient response (including at least 6 sessions of bilateral ECT) OR patients who are kept stable with maintenance ECT, but who relapse after discontinuation of this maintenance ECT are also eligible, but need to fulfill all other inclusion criteria. Besides the above defined treatments, we will evaluate the adequacy of all attempted antidepressant treatments, including off-label strategies such as esketamine. In case on- or off-label treatments are available to the patient, but have not been tried adequately, these options are discussed with and offered to the patient before offering deep brain stimulation. 3) HAM-D total >= 18 4) Illness duration > 2 years 5) Age: 20-75 years old
Exclusion criteria
Exclusion criteria: 1) Bipolar Disorder 2) Schizophrenia /history of psychosis unrelated to MDD 3) Alcohol or substance abuse (including benzodiazepines) during last 6 months, excluding nicotine use 4) Primary and severe personality disorder diagnosed independently from TRD 5) Explicit suicidal plans requiring hospitalization in a closed ward 6) Contraindications to have surgery 7) Depression as a result of acute brain damage (e.g. stroke / hemorrhage) 8) Parkinson*s disease, Tourette syndrome, dementia, epilepsy, tic disorder 9) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in scores between active and sham DBS on the Hamilton Depression Rating Scale, 17 items (HAM-D-17, range 0-52 with higher scores indicating more symptoms); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of responders after the open label phase (defined as a >=50% reduction of the baseline HAM-D-17 score). Change over time of HAM-D score, MADRS score, and IDS-SR score. Adverse events. Change of cognitive functions (measured with neuropsychological tests), quality of life (using questionnaires), personality (using questionnaires), brain activity (MRI scans), and physical functioning. Acute changes before and after turning on DBS (measured with a diary). | — |
Countries
Netherlands
Outcome results
None listed