Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 schizotypal personality disorder) or B (e.g., borderline or antisocial personality disorder); - Brain pathology, such as moderate or marked cerebral atrophy, stroke, tumor or previous neurosurgical procedures (i.e. capsulotomy etc), history of cognitive impairment and cognitive deterioration (Addenbrooke's Cognitive Examination ACE score of \< 80). - Contra-indications to surgery, anaesthesia, or MRI - compulsory hospitalization/ care; pregnant or nursing patients Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 the following: lithium, clonazepam * Adequate trial of CBT (Exposure Therapy and Response Prevention) (intolerance or \>15 sessions) * Ability to provide informed consent 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 schizotypal personality disorder) or B (e.g., borderline or antisocial personality disorder); * Brain pathology, such as moderate or marked cerebral atrophy, stroke, tumor or previous neurosurgical procedures (i.e. capsulotomy etc), history of cognitive impairment and cognitive deterioration (Addenbrooke's Cognitive Examination ACE score of \< 80). * Contra-indications to surgery, anaesthesia, or MRI * compulsory hospitalization/ care; pregnant or nursing patients

Treatments Being Tested

DEVICE

Deep Brain Stimulation

surgical procedure

Locations (8)

CHU Henri Mondor
Créteil, France
University Hospital of Grenoble Michallon
Grenoble, France
Chu Nice - Hopital Pasteur
Nice, France
APHP La Pitié Salpêtrière
Paris, France
Ghu Sainte Anne
Paris, France
Universitätsklinikum Köln (AöR)
Cologne, Germany
Djurfeldt
Stockholm, Sweden
Hôpitaux Universitaires de Genève
Geneva, Switzerland