NCT02844049 European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
| NCT ID | NCT02844049 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2016-09 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2016-09 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Mircea Polosan, MD PhD
PRINCIPAL INVESTIGATOR
University Hospital, Grenoble
Frequently Asked Questions
Who can join the NCT02844049 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 69 Years, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02844049 currently recruiting?
Yes, NCT02844049 is actively recruiting participants. Contact the research team at SDavidTchouda@chugrenoble.fr for enrollment information.
Where is the NCT02844049 trial being conducted?
This trial is being conducted at Créteil, France, Grenoble, France, Nice, France, Paris, France and 4 additional locations.
Who is sponsoring the NCT02844049 clinical trial?
NCT02844049 is sponsored by University Hospital, Grenoble. The principal investigator is Mircea Polosan, MD PhD at University Hospital, Grenoble. The trial plans to enroll 60 participants.