European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: f
View:

• 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 the following: lithium, clonazepam

• Adequate trial of CBT (Exposure Therapy and Response Prevention) (intolerance or \>15 sessions)

• Ability to provide informed consent

Locations
Other Locations
France
CHU Henri Mondor
COMPLETED
Créteil
University Hospital of Grenoble Michallon
RECRUITING
Grenoble
Chu Nice - Hopital Pasteur
RECRUITING
Nice
APHP La Pitié Salpêtrière
RECRUITING
Paris
Ghu Sainte Anne
RECRUITING
Paris
Germany
Universitätsklinikum Köln (AöR)
RECRUITING
Cologne
Sweden
Djurfeldt
RECRUITING
Stockholm
Switzerland
Hôpitaux Universitaires de Genève
RECRUITING
Geneva
Contact Information
Primary
Sandra David-tchouda, MD
SDavidTchouda@chugrenoble.fr
+33476767186
Backup
Sandrine Massicot, Master
smassicot@chu-grenoble.fr
+33476768860
Time Frame
Start Date: 2016-09
Estimated Completion Date: 2027-04
Participants
Target number of participants: 60
Treatments
Active_comparator: Deep Brain Stimulation
DBS surgical procedure scheduled and realized
No_intervention: Control group
medical treatment (psycho- and pharmaco-therapy) will continue to be given and optimized according to the defined BMT strategies and criteria
Sponsors
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov