Identifying factors that help predict improvement with deep brain stimulation (a surgical treatment) for obsessive-compulsive disorder

Not Applicable

• Conditions: Health Condition 1: F422- Mixed obsessional thoughts and acts

• Registration Number: CTRI/2020/03/024131
• Lead Sponsor: Wellcome Trust DBT India Alliance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive severity scale (Y-BOCS)Timepoint: Yale Brown Obsessive Compulsive severity scale (Y-BOCS)

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions-severity, Hamilton depression rating scale, Hamilton anxiety rating scale, WHO-Quality of life -BREF, WHO-Disability Assessment ScheduleTimepoint: 12 months post-surgery, assessment conducted every 1 months