RecruitingNot ApplicableNCT02844049

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


Sponsor

University Hospital, Grenoble

Enrollment

60 participants

Start Date

Sep 1, 2016

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 69 Years

Inclusion Criteria7

  • OCD for \> 5 years
  • YBOCS\> 25 and/or YBOCS sub-scale \>15
  • GAF\< 45
  • 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 Criteria9

  • 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

Interventions

DEVICEDeep 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

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NCT02844049


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