Treatment-resistant depression
Conditions
Interventions
Deep brain stimulation (DBS) of the superolateral branch of the medial forebrain bundel (slMFB)
Sponsors
Board of directors, Amsterdam UMC (location AMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1) A primary diagnosis of major depressive disorder (single episode or recurrent; 296.2 or 296.3) according to the DSM-5 criteria; 2) Treatment-resistance, which is defined in detail in Chapter 6.3; 3) HAM-D total = 18; 4) Illness duration > 2 years; 5) Disabling severity with substantial functional impairment; 6) Age: 20-70 years old; 7) Dutch or English speaking and able to answer the study questions; 8) Motivated and capable to attend the study visits; 9) Able to fully understand the consequences of the procedure; 10) Mentally capable to make his or her own choice without coercion; 11) Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Bipolar disorder; 2) Schizophrenia / history of psychosis unrelated to MDD; 3) Alcohol or substance abuse (including benzodiazepines) during the last 6 months; 4) Primary and severe personality disorder diagnosed independently from TRD; 5) Explicit suicidal plans requiring hospitalization in a closed ward; 6) Unstable physical condition or general 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 |
|---|---|
| Secondary outcomes include percentage of responders after the open label phase (defined as a =50% reduction of the baseline HAM-D-17 score), (serious) adverse events, qualtiy of life, (neuro)psychological outcomes and neuro-imaging. | — |
Contacts
Public ContactIsidoor Bergfeld
Academisch Medisch Centrum, Amsterdam
Outcome results
None listed