Deep brain stimulation of the medial forebrain bundle for treatment-resistant depressio
- Conditions
- Treatment-resistant depression
- Registration Number
- NL-OMON20193
- Lead Sponsor
- Board of directors, Amsterdam UMC (location AMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 48
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.