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

Overview

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.

Interventions

• Device Deep Brain Stimulation
  surgical procedure

Primary outcome measures

• 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 [Time frame: 1 year]

Secondary outcome measures (12)

• Psychiatric assessment n°1 [Time frame: 1 year]
• Psychiatric assessment n°2 [Time frame: 1 year]
• Psychiatric assessment n°3 [Time frame: 1 year]
• Psychiatric assessment n°4 [Time frame: 1 year]
• Psychiatric assessment n°5 [Time frame: 1 year]
• Psychiatric assessment n°6 [Time frame: 1 year]
• Psychiatric assessment n°7 [Time frame: 1 year]
• Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1 [Time frame: 1 year]
• Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2 [Time frame: 1 year]
• side effects [Time frame: 1 year]
• Psychiatric markers n°1 [Time frame: 1 year]
• Psychiatric markers n°2 [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 5 centers

• CHU Henri Mondor — Créteil
• University Hospital of Grenoble Michallon — Grenoble
• Chu Nice - Hopital Pasteur — Nice
• APHP La Pitié Salpêtrière — Paris
• Ghu Sainte Anne — Paris

Germany · 1 center

• Universitätsklinikum Köln (AöR) — Cologne

Sweden · 1 center

• Djurfeldt — Stockholm

Switzerland · 1 center

• Hôpitaux Universitaires de Genève — Geneva

Publications

• Subramaniam M, Soh P, Vaingankar JA, Picco L, Chong SA. Quality of life in obsessive-compulsive disorder: impact of the disorder and of treatment. CNS Drugs. 2013 May;27(5):367-83. doi: 10.1007/s40263-013-0056-z. PMID 23580175
• 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. Subt PMID 19005196
• 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. PMID 25085317
• Eitan R, Shamir RR, Linetsky E, Rosenbluh O, Moshel S, Ben-Hur T, Bergman H, Israel Z. Asymmetric right/left encoding of emotions in the human subthalamic nucleus. Front Syst Neurosci. 2013 Oct 29;7:69. doi: 10.3389/fnsys.2013.00069. eCollection 2013. PMID 24194703
• 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. PMID 26833615
• 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. PMID 21520240
• 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. PMID 23715912

Identifiers

NCT: NCT02844049 · 38RC15.344

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗