A clinical trial to compare the effectiveness of repeated infusions of Ketamine and Midazolam in Obsessive Compulsive disorders that have not responded to previuous treatments with medicines or psychotherapy, and to see how this relates to the Brain Dericed Neurotrophic Factor(BDNF).

Phase 2

Not yet recruiting

Brief Summary: The study is a double-blind randomized controlled trial to assess and compare the effectiveness of repeated ketamine infusions and repeated midazolam infusions in treatment non-responding Obsessive Compulsive Disorder and to assess their relation with BDNF. The study will be conducted at a premiere psychiatric institute in India. The primary outcome measures will be 1) scores on the Dimensional Y-BOCS 1hour before ,and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and after 4 weeks of the last infusion, and 2) plasma levels of BDNF 1 day before 1st infusion, after the 3rd infusion/after 1st week and after the 6th infusion/after 2nd week. The secondary outcome measures will be scores on the Montgomery Asberg Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Clinician Administered Dissociative State Scale and the Systemic Assessment for Treatment Emergent Events Scale, 1 hour before, and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and after 4 weeks of last infusion.

Recruitment & Eligibility

Inclusion Criteria

Patients of either sex, aged between 21-50 years.
Inpatients fulfilling ICD 10-DCR diagnostic criteria for OCD but are treatment non-responders.
Patients giving written informed consent.

Exclusion Criteria

Any other major co-morbid psychiatric diagnoses (except depression and mild to moderate anxiety) and substance dependence excluding nicotine & caffeine.
Presence of an acute/unstable medical or neurological condition.
Pregnancy or lactation.
Childhood onset OCD (age at onset <10 years) [Geller et al, 1998].

Primary Outcome Measures

Name	Time	Method
Score on the Dimensional Yale Brown Obsessive Compulsive Scale(DY-BOCS)	DY-BOCS-1 hour before and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and 4 weeeks after last infusion. \| Plasma BDNF-1 day before 1sy infusion, after 3rd infusion or 1st week and after 6th infusion or 2nd week.
Plasma BDNF levels as measured by Sandwich ELISA method	DY-BOCS-1 hour before and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and 4 weeeks after last infusion. \| Plasma BDNF-1 day before 1sy infusion, after 3rd infusion or 1st week and after 6th infusion or 2nd week.

Secondary Outcome Measures

Name	Time	Method
Score on the Montgomery Asberg Depression Rating scale (MADRS).	Score on the Hamilton Anxiety Rating Scale(HAM-A)

Locations (1): Central Institute of Psychiatry
🇮🇳
Ranchi, JHARKHAND, India
Central Institute of Psychiatry
🇮🇳Ranchi, JHARKHAND, India
Dr Basudeb Das
Principal investigator
919431108544
basudebdas@cipranchi.nic.in