跳至主要内容
临床试验/NCT02844049
NCT02844049招募中不适用

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

University Hospital, Grenoble8 个研究点 分布在 4 个国家目标入组 60 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
8
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • OCD for > 5 years
  • YBOCS> 25 and/or YBOCS sub-scale >15
  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 1 year

QOL assessment : scores at SF36

次要结局

  • Psychiatric assessment n°5(1 year)
  • Psychiatric assessment n°1(1 year)
  • Psychiatric assessment n°2(1 year)
  • Psychiatric assessment n°3(1 year)
  • Psychiatric assessment n°4(1 year)
  • Psychiatric assessment n°6(1 year)
  • Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD(1 year)
  • Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2(1 year)
  • Neuropsychological markers n°6(1 year)
  • Psychiatric assessment n°7(1 year)
  • Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1(1 year)
  • side effects(1 year)
  • Psychiatric markers n°1(1 year)
  • Psychiatric markers n°2(1 year)
  • Neurological markers n°3(1 year)
  • Neuropsychological markers n°4(1 year)
  • Neuropsychological markers n°5(1 year)
  • Neuropsychological markers(1 year)
  • Per-op electrophysiological mapping of the STN activity n°1(1 year)
  • Per-op electrophysiological mapping of the STN activity n°3(1 year)
  • Per-op electrophysiological mapping of the STN activity n°2(1 year)
  • Per-op electrophysiological mapping of the STN activity n°4(1 year)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (8)

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