Status:
COMPLETED
SubGenual CG25 Deep Brain Stimulation in Severe Resistant Depression
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Depression
Eligibility:
All Genders
30-55 years
Brief Summary
Despite the availability of several treatments, a number of patients with major depression are refractory to therapeutical approaches and therefore suffer from chronic handicap. For these severe patie...
Detailed Description
The protocol involves assessment of effects of CG25 (subgenual cingulate area-Brodmann 25) DBS on mood, anxiety, apathy, anhedonia, psychomotor retardation, functional state as well as safety and tole...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men and women between 30 and 55 years old
- Women at a reproductive age will have to be under successful contraceptive and will undergo a pregnancy test before inclusion
- Patient suffering from major unipolar depression refractory to conventional therapies
- Chronic depression with ongoing depressive episode \> 12 months.
- 4 unsuccessful therapies attempted to treat the ongoing episode, including anti-depressant monotherapies, potentialisation of antidepressant treatments, validated structured psychotherapies, electro-convulsive therapy performed accordingly to ANAES ( Agence Nationale d'Accréditation et d'Evaluation en Santé-the French Health Authority) recommendations (at least 6 sessions with bilateral technique and length control of convulsive crisis).
- Ambulatory or hospital care
- Able to speak French, understand study procedures and complete questionnaires.
- Covered by french social health system
- Living in Rhone-Alpes area without plan to move in the next 2 years
- Exclusion criteria:
- History of cerebral surgery
- Neurological disorder that can interfere with evaluation of surgical procedure or significant cognitive impairment (Mattis score \< 30)
- Psychiatric disorder responsible for comorbidity with the major depressive episode (schizophrenia and other delirium, diagnosed anxiety except generalized anxiety disorder, substance dependency)
- Personality disorder of A and B clusters
- Suicidal ideas at evaluation, intention for auto-destruction, repeated suicidal attempts in the last 3 years with emergency care or hospitalization
- Severe somatic pathology or contraindication to surgery due to heart defibrillator/pacemaker or other implanted device.
- A decrease superior to or equal to 20% in the 17-Hamilton Depression Rating Scale score between inclusion and pre-surgery evaluation
- Drug dependency including alcohol in the last 12 months with history of abuse in the last 6 months, with the exception of nicotine
- Persons protected by the law.
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01834560
Start Date
December 1 2007
End Date
December 1 2017
Last Update
October 11 2018
Active Locations (1)
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1
Neurosurgery department
Grenoble, France, 38043