NL-OMON20193Not yet recruitingNot Applicable
Deep brain stimulation of the medial forebrain bundle for treatment-resistant depression
Board of directors, Amsterdam UMC (location AMC)0 sites48 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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