Actively Recruiting
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
Led by University Hospital, Grenoble · Updated on 2023-11-29
60
Participants Needed
8
Research Sites
552 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. These resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate neural networks. Although promising, these results need nevertheless to be replicated and confirmed within a larger cohort of patients and considering a different main objective, instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond symptom reduction, health-related quality of life (QoL) represents a more important objective of a treatment, as it includes both the individual's functional status and the individual's subjective perception of the impact of the illness on the patient's life. STN DBS induces significant clinical improvement, which may not be proportional to the QoL gain. Consequently, QoL appears to be a better outcome to target in the coming studies than clinical improvement alone. THe investigators thus propose a prospective study assessing the QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT) at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus BMT alone.
CONDITIONS
Official Title
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of OCD for more than 5 years
- Yale-Brown Obsessive Compulsive Scale (YBOCS) score greater than 25 and/or YBOCS sub-scale greater than 15
- Global Assessment of Functioning (GAF) score less than 45
- At least 3 documented trials of serotonin reuptake inhibitors including clomipramine for 10-12 weeks at adequate dose
- SRI augmentation for more than 4 weeks with at least one antipsychotic and one of the following: lithium or clonazepam
- Adequate trial of cognitive behavioral therapy (CBT) including exposure and response prevention, with intolerance or more than 15 sessions
- Ability to provide informed consent
You will not qualify if you...
- Hoarding as the only OCD symptom
- Poor insight OCD with Brown Assessment of Beliefs Scale (BABS) score greater than 12
- Lifetime diagnosis of psychosis or bipolar disorder
- Substance abuse or dependence within the previous six months
- Montgomery and Asberg Depression Rating Scale (MADRS) suicidality item score greater than 2
- Current DSM-5 personality disorder of Cluster A or B
- Brain pathology such as moderate or marked cerebral atrophy, stroke, tumor, previous neurosurgical procedures, cognitive impairment or deterioration (Addenbrooke's Cognitive Examination score less than 80)
- Contraindications to surgery, anesthesia, or MRI
- Compulsory hospitalization or care
- Pregnant or nursing patients
AI-Screening
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Trial Site Locations
Total: 8 locations
1
CHU Henri Mondor
Créteil, France
Completed
2
University Hospital of Grenoble Michallon
Grenoble, France
Actively Recruiting
3
Chu Nice - Hopital Pasteur
Nice, France
Actively Recruiting
4
APHP La Pitié Salpêtrière
Paris, France
Actively Recruiting
5
Ghu Sainte Anne
Paris, France
Actively Recruiting
6
Universitätsklinikum Köln (AöR)
Cologne, Germany
Actively Recruiting
7
Djurfeldt
Stockholm, Sweden
Actively Recruiting
8
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Actively Recruiting
Research Team
S
Sandra David-tchouda, MD
CONTACT
S
Sandrine Massicot, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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