Health Condition 1: F422- Mixed obsessional thoughts and acts
Conditions
Interventions
Intervention1: Deep brain stimulation: Intracranial electrodes attached to a stimulator to stimulate the subthalamic nucleus in the brain. The treatment involves a one-time surgical implantation of th
Sponsors
Wellcome Trust DBT India Alliance
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Yale Brown Obsessive Compulsive severity scale (Y-BOCS)Timepoint: Yale Brown Obsessive Compulsive severity scale (Y-BOCS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactShyam Sundar Arumugham
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Outcome results
None listed