Last updated: November 28, 2023
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting
Phase
N/A
Condition
Obsessive-compulsive Disorder
Kleptomania
Anxiety Disorders
Treatment
Deep Brain Stimulation
Clinical Study ID
NCT02844049
38RC15.344
Ages 18-69 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- OCD for > 5 years
- YBOCS> 25 and/or YBOCS sub-scale >15
- GAF< 45
- 3 or more documented SRI trials, including clomipramine (10-12 weeks at adequate dose)
- SRI augmentation for > 4 weeks with at least one antipsychotic and with one of thefollowing: lithium, clonazepam
- Adequate trial of CBT (Exposure Therapy and Response Prevention) (intolerance or >15sessions)
- Ability to provide informed consent
Exclusion
Exclusion Criteria:
- Hoarding (if the only OCD symptom)
- OCD with poor insight (BABS score > 12)
- Lifetime diagnosis of psychosis or bipolar disorder;
- Substance abuse or dependence within the previous six months;
- Baseline Montgomery and Asberg (MADRS) suicidality item (item 10) score >2;
- Current DSM-5 personality disorder of Cluster A (e.g., paranoid or schizotypalpersonality disorder) or B (e.g., borderline or antisocial personality disorder);
- Brain pathology, such as moderate or marked cerebral atrophy, stroke, tumor orprevious neurosurgical procedures (i.e. capsulotomy etc), history of cognitiveimpairment and cognitive deterioration (Addenbrooke's Cognitive Examination ACE scoreof < 80).
- Contra-indications to surgery, anaesthesia, or MRI
- compulsory hospitalization/ care; pregnant or nursing patients
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Deep Brain Stimulation
Phase:
Study Start date:
September 01, 2016
Estimated Completion Date:
April 30, 2027
Study Description
Connect with a study center
CHU Henri Mondor
Creteil,
FranceCompleted
University Hospital of Grenoble Michallon
Grenoble,
FranceActive - Recruiting
Chu Nice - Hopital Pasteur
Nice,
FranceActive - Recruiting
APHP La Pitié Salpêtrière
Paris,
FranceActive - Recruiting
Ghu Sainte Anne
Paris,
FranceActive - Recruiting
Universitätsklinikum Freiburg (i.Br.)
Freiburg,
GermanySite Not Available
Universitätsklinikum Köln (AöR)
Koln,
GermanyActive - Recruiting
Hadassah Medical Center The Hebrew University
Jerusalem,
IsraelSite Not Available
DISS - Università degli Studi di Milano
Milano,
ItalySite Not Available
Djurfeldt
Stockholm,
SwedenActive - Recruiting
Karolinska University Hospital
Stockholm,
SwedenSite Not Available
Hôpitaux Universitaires de Genève
Geneve,
SwitzerlandActive - Recruiting
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