Clinical trial NCT02844049: European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
Official title: European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Deep Brain Stimulation
Quality of Life
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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 outcomes:
measure: Assessment of the impact of DBS+BMT versus BMT alone on a measure of Quality of life in resistant OCD patients at 1-year follow-up
timeFrame: 1 year
Secondary outcomes:
measure: Psychiatric assessment n°1
timeFrame: 1 year
measure: Psychiatric assessment n°2
timeFrame: 1 year
measure: Psychiatric assessment n°3
timeFrame: 1 year
measure: Psychiatric assessment n°4
timeFrame: 1 year
measure: Psychiatric assessment n°5
timeFrame: 1 year
measure: Psychiatric assessment n°6
timeFrame: 1 year
measure: Psychiatric assessment n°7
timeFrame: 1 year
measure: Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1
timeFrame: 1 year
measure: Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2
timeFrame: 1 year
measure: side effects
timeFrame: 1 year
measure: Psychiatric markers n°1
timeFrame: 1 year
measure: Psychiatric markers n°2
timeFrame: 1 year
measure: Neurological markers n°3
timeFrame: 1 year
measure: Neuropsychological markers n°4
timeFrame: 1 year
measure: Neuropsychological markers n°5
timeFrame: 1 year
measure: Neuropsychological markers n°6
timeFrame: 1 year
measure: Neuropsychological markers
timeFrame: 1 year
measure: Per-op electrophysiological mapping of the STN activity n°1
timeFrame: 1 year
measure: Per-op electrophysiological mapping of the STN activity n°2
timeFrame: 1 year
measure: Per-op electrophysiological mapping of the STN activity n°3
timeFrame: 1 year
measure: Per-op electrophysiological mapping of the STN activity n°4
timeFrame: 1 year
measure: Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD
timeFrame: 1 year
Other outcomes:
Locations:
city: Creteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: University Hospital of Grenoble Michallon
city: Nice
country: France
facility: Chu Nice - Hopital Pasteur
city: Paris
country: France
facility: APHP La Pitié Salpêtrière
city: Paris
country: France
facility: Ghu Sainte Anne
city: Koln
country: Germany
facility: Universitätsklinikum Köln (AöR)
city: Stockholm
country: Sweden
facility: Djurfeldt
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
affiliation: University Hospital, Grenoble
name: Mircea Polosan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
citation: Kohl S, Schonherr DM, Luigjes J, Denys D, Mueller UJ, Lenartz D, Visser-Vandewalle V, Kuhn J. Deep brain stimulation for treatment-refractory obsessive compulsive disorder: a systematic review. BMC Psychiatry. 2014 Aug 2;14:214. doi: 10.1186/s12888-014-0214-y.
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citation: Mataix-Cols D, Fernandez de la Cruz L, Nordsletten AE, Lenhard F, Isomura K, Simpson HB. Towards an international expert consensus for defining treatment response, remission, recovery and relapse in obsessive-compulsive disorder. World Psychiatry. 2016 Feb;15(1):80-1. doi: 10.1002/wps.20299. No abstract available.
citation: Piallat B, Polosan M, Fraix V, Goetz L, David O, Fenoy A, Torres N, Quesada JL, Seigneuret E, Pollak P, Krack P, Bougerol T, Benabid AL, Chabardes S. Subthalamic neuronal firing in obsessive-compulsive disorder and Parkinson disease. Ann Neurol. 2011 May;69(5):793-802. doi: 10.1002/ana.22222. Epub 2010 Dec 28.
citation: Ooms P, Mantione M, Figee M, Schuurman PR, van den Munckhof P, Denys D. Deep brain stimulation for obsessive-compulsive disorders: long-term analysis of quality of life. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):153-8. doi: 10.1136/jnnp-2012-302550. Epub 2013 May 28.