Actively Recruiting

Phase Not Applicable
Age: 18Years - 69Years
All Genders
NCT02844049

European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS

Led by University Hospital, Grenoble · Updated on 2023-11-29

60

Participants Needed

8

Research Sites

552 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS

Who Can Participate

Age: 18Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of OCD for more than 5 years
  • Yale-Brown Obsessive Compulsive Scale (YBOCS) score greater than 25 and/or YBOCS sub-scale greater than 15
  • Global Assessment of Functioning (GAF) score less than 45
  • At least 3 documented trials of serotonin reuptake inhibitors including clomipramine for 10-12 weeks at adequate dose
  • SRI augmentation for more than 4 weeks with at least one antipsychotic and one of the following: lithium or clonazepam
  • Adequate trial of cognitive behavioral therapy (CBT) including exposure and response prevention, with intolerance or more than 15 sessions
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Hoarding as the only OCD symptom
  • Poor insight OCD with Brown Assessment of Beliefs Scale (BABS) score greater than 12
  • Lifetime diagnosis of psychosis or bipolar disorder
  • Substance abuse or dependence within the previous six months
  • Montgomery and Asberg Depression Rating Scale (MADRS) suicidality item score greater than 2
  • Current DSM-5 personality disorder of Cluster A or B
  • Brain pathology such as moderate or marked cerebral atrophy, stroke, tumor, previous neurosurgical procedures, cognitive impairment or deterioration (Addenbrooke's Cognitive Examination score less than 80)
  • Contraindications to surgery, anesthesia, or MRI
  • Compulsory hospitalization or care
  • Pregnant or nursing patients

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 8 locations

1

CHU Henri Mondor

Créteil, France

Completed

2

University Hospital of Grenoble Michallon

Grenoble, France

Actively Recruiting

3

Chu Nice - Hopital Pasteur

Nice, France

Actively Recruiting

4

APHP La Pitié Salpêtrière

Paris, France

Actively Recruiting

5

Ghu Sainte Anne

Paris, France

Actively Recruiting

6

Universitätsklinikum Köln (AöR)

Cologne, Germany

Actively Recruiting

7

Djurfeldt

Stockholm, Sweden

Actively Recruiting

8

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Actively Recruiting

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Research Team

S

Sandra David-tchouda, MD

CONTACT

S

Sandrine Massicot, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS | DecenTrialz