NCT05577585

Ketamine in OCD: Efficacy and Effects on Stress and Cognition

Ketamine Therapy in Obsessive-compulsive Disorder and Its Effects on Neuropsychological Function Under Stress in a Cross-over Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this trial is to demonstrate therapeutic efficacy of low dose ketamine in patients with OCD. We expect that ketamine will alleviate symptoms in the hours following application, but also - if effective - that the anti-OCD effects might last for several days after a single infusion.

Detailed description

This study will apply a randomized, double blind, comparator-controlled cross-over design and will be conducted at the Department of Psychiatry and Psychotherapy of the Medical University of Vienna. We will include 30 participants with a primary diagnosis of OCD. Participants will undergo ketamine and comparator infusions in either inpatient- or outpatient settings to assess the therapeutic capabilities of ketamine in OCD. Furthermore, participants' neurocognitive function and stress responses will be tested with four neurocognitive tasks and a cold pressor test paradigm. Also EEG measurements will take place during and before infusions in this phase. Study subjects will be given an option to participate in an open-label follow up with up to 8 infusions over a period of a month. Open-label ketamine treatment will be compared to treatment as usual. After finishing open label treatment an additional EEG measurement will take place.

Conditions

• Obsessive-Compulsive Disorder
• Psychiatric Disorder

Interventions

Type	Name	Description
DRUG	Ketamine 50 MG/ML Blinded	See also Arm description
DRUG	Midazolam	See also Arm description
DRUG	Ketamine 50 MG/ML Open Label	Open Label Follow Up (up to 8 Infusions)
OTHER	Treatment as Usual (TAU)	Treatment as Usual may include psychotherapy, pharmacotherapy, physiotherapy, ergotherapy, or a combination of these-at the discretion of the treating physician, independently of the study.

Timeline

• Start date: 2022-10-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-10-13
• Last updated: 2025-06-25

Locations

1 site across 1 country: Austria