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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).

Effectiveness of Repeated Ketamine Infusions in Treatment Non-Responding Obsessive Compulsive Disorder And its Relation to BDNF: a Double-Blind Randomized COntrolled Trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035229
Enrollment
30
Registered
2021-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F42- Obsessive-compulsive disorder

Interventions

Intervention1: Intervention:Injection Ketamine: 6 infusions of Injection Ketamine 0.5 mg/kg body weight over 2 weeks. Control Intervention1: Comparator Agent: Injection MIdazolam: 6 infusions of Injec

Sponsors

Central Institute of Psychiatry CIP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex, aged between 21-50 years. 2. Inpatients fulfilling ICD 10-DCR diagnostic criteria for OCD but are treatment non-responders. 3. Patients giving written informed consent.

Exclusion criteria

Exclusion criteria: 1. Any other major co-morbid psychiatric diagnoses (except depression and mild to moderate anxiety) and substance dependence excluding nicotine & caffeine. 2. Presence of an acute/unstable medical or neurological condition. 3. Pregnancy or lactation. 4. Childhood onset OCD (age at onset

Design outcomes

Primary

MeasureTime frame
Score on the Dimensional Yale Brown Obsessive Compulsive Scale(DY-BOCS) Plasma BDNF levels as measured by Sandwich ELISA methodTimepoint: 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

MeasureTime frame
Score on the Montgomery Asberg Depression Rating scale (MADRS). Score on the Hamilton Anxiety Rating Scale(HAM-A) Score on the Clinician-Administered Dissociative States Scale(CADSS), and Score on the Systemic Assessment for Treatment Emergent Events(SAFTEE)Timepoint: 1 hour before and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and 4 weeeks after last infusion.

Countries

India

Contacts

Public ContactDr Varun S Mehta

Central Institute of Psychiatry

vs_mehta@yahoo.co.in9204858189

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026