CTRI/2020/03/024131Not yet recruiting未知
Identification of biomarkers that predict response to deep brain stimulation oversubthalamic nucleus in obsessive-compulsive disorder
Wellcome Trust DBT India Alliance0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •i.Age between 18 to 60 years.
- •ii.Primary diagnosis of obsessive-compulsive disorder satisfying the DSM-5 criteria2 , established using Mini International Neuropsychiatric Interview-7.0.2. .
- •iii.Duration of OCD ï?³ 5 years.
- •iv.Yale-Brown Obsessive Compulsive Scale (YBOCS) score of ï?³ 28 or ï?³ 14 if the subject has either predominantly obsessions or compulsions alone.
- •v.Clinical Global Impressions â?? Severity (CGI-S) scale of ï?³ 5
- •vi.Disability of ï?³ 40% as evaluated by Indian Disability Evaluation and Assessment Scale (IDEAS).
- •vii.Failure to obtain meaningful improvement in OCD despite adequate trial with standard treatment strategies which should include:
- •a.At least 3 trials of serotonin reuptake inhibitors (SRIs), one of which should be clomipramine, which were either ineffective or poorly tolerated. An adequate trial includes recommended dose of SRIs for ï?³ 12 weeks duration each46.
- •b.Augmentation of SRIs with at least 2 agents for ï?³ 6 weeks, one of which should be either risperidone or aripiprazole.
- •c.Trial of structured behaviour therapy/cognitive behaviour therapy for at least 20 sessions or demonstrated inability to tolerate the anxiety due to therapy.
Exclusion Criteria
- •i. Diagnosis of bipolar disorder, psychotic disorder of ³ 3 months duration as assessed
- •with MINI-7.0.2
- •ii. Current substance use disorder (except caffeine or nicotine use disorder) or Major
- •depressive episode or current high suicidality, as assessed with MINI-7.0.2.
- •iii. Severe personality disorder as assessed with Structured Clinical Assessment of
- •DSM-5-PD version
- •iv. Clinically significant abnormality on magnetic resonance imaging (MRI) of the brain.
- •v. Pregnancy, contraindication for DBS/anaesthesia/preoperative MRI, inability to
- •comply with surgical requirements.
Investigators
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