NL-OMON32776
Completed
Phase 2
Deep Brain Stimulation in Treatment-refractory patients with Major Depressive Disorder; A pilot study - DBS in Depression
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 25
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Primary diagnosis: MDD (single episode or recurrent; 296\.2 or 296\.3\) according to the DSM\-IV criteria based on a psychiatric interview and the SCID as diagnostic instrument
- •\- Illness duration \> 2 years, chronic MDD
- •\- HAM\-D total above or equal : 18 (measured twice, at least two weeks apart with the last assessment just before surgery)
- •\- Disabling severity with substantial functional impairment according to the DSM\-IV criterion C and a Global Assessment of Function (GAF) score of 45 or less
- •\- The level of impairment must have been persistent for at least 2 years
- •\- Age: 18\-65 years old
- •\- Written informed consent
- •\- Able to fully understand the consequences of the procedure (IQ \> 80\)
- •\- Dutch or English speaking and able to answer the study questions
- •\- Capable to make his or her own choice without coercion
Exclusion Criteria
- •\- Unstable physical condition
- •\- Organic cause
- •\- Parkinson\*s disease, dementia, epilepsy
- •\- Schizophrenia /history of psychosis unrelated to MDD
- •\- Alcohol or substance abuse (including benzodiazepines) during last 6 months
- •\- Current Tic disorder
- •\- Antisocial personality disorder
- •\- Bipolar Disorder
- •\- Pregnancy
- •\- Mental retardation
Outcomes
Primary Outcomes
Not specified
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