• Deep Brain Stimulation and Obsessive-compulsive Disorder

  NCT01329133

  CompletedInterventionalPhase 3Updated Feb 6, 2020
• Deep Brain Stimulation for Severe Obsessive Compulsive Disorder

  NCT02655926

  CompletedInterventionalNot ApplicableUpdated Mar 3, 2017
• Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

  NCT00057603

  CompletedInterventionalNot ApplicableUpdated Nov 9, 2011
• Deep Brain Stimulation for Obsessive-compulsive Disorder

  NCT06628752

  RecruitingInterventionalNot ApplicableUpdated Oct 17, 2024
• Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)

  NCT01985815

  CompletedInterventionalPhase 1Phase 2Updated Nov 15, 2013
• Effectiveness of Deep Brain Stimulation for Treating People With Treatment Resistant Obsessive-Compulsive Disorder

  NCT00640133

  Unknown statusInterventionalPhase 4Updated Jul 29, 2024

ClinicalTrials.gov ID

NCT02844049

Lead Sponsor

University Hospital, GrenobleOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Nov 29, 2023Actual

Start Date

Sep 2016Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Apr 2027Estimated

Official Title

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

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.

Detailed Description

The study will focus on an innovative therapeutic strategy (DBS) and on an original objective, quality of life, which is considered to better reflect the impact of a therapeutic strategy. Moreover, the study will help to define the predictive biomarkers /biosignatures of response to STN DBS in OCD.

• Obsessive-Compulsive Disorder

• Deep Brain Stimulation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, GrenobleOTHER

philippe.domenech@ghu-paris.fr

diana.pascal@ki.se+46 72 211 9562