Ketamine and Stress in OCD

Obsessive-Compulsive Disorder Clinical Trial

— KET-OCD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577585
• Other study ID #: v3 09.02.2022
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Medical University of Vienna
• Contact: Christoph Kraus, MD PhD
• Phone: +4314040035680
• Email: christoph.kraus[@]muv.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary diagnosis of obsessive-compulsive disorder
• A score of 16 or higher on the Yale-Brown Obsessive Compulsive Scale and ability to provide written informed consent
• At least one previous treatment for OCD

Exclusion Criteria:

• Any history of current or past psychotic disorder
• A manic episode within the preceding three years
• Current or unstable remitted substance abuse or dependence except nicotine
• Pregnancy or elevated risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception
• Any current severe personality disorder except comorbid anankastic personality disorder
• Morbus Raynaud
• Inability to follow the study protocol or adhere to operational requirements
• Current and unstable suicidality
• Unstable hypertension
• Untreated hyperthyroidism
• Any unstable cardiovascular disease
• Untreated disorders severely affecting the HPA-axis (M.Addison, M.Cushing)
• Current pharmacological therapy severely affecting the HPA-axis like corticosteroids or ACTH

Related Conditions & MeSH terms

• Mental Disorders
• Obsessive-Compulsive Disorder
• Problem Behavior
• Psychiatric Disorder

Intervention

Drug:
• Ketamine 50 MG/ML
See also Arm description
• Midazolam
See also Arm description
• Ketamine 50 MG/ML
Open Label Follow Up (up to 8 Infusions)

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Psychiatry and Psychotherapy	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of OCD symptoms (Y-BOCS)	There will be a change of severity of obsessive and compulsive symptoms seven days after ketamine infusion compared to midazolam infusion as measured with Y-BOCS.	In total 7 YBOCS assessments will take place between week 1 and 5.
Secondary	Change of OCD symptoms (OCD-VAS)	There will be a change in patients' severity of obsessive and compulsive symptoms as measured with OCD-VAS 24 hours after ketamine infusion compared to midazolam infusion.	in each arm 24 hours after infusion
Secondary	Change of OCD symptoms (Y-BOCS)	There will be a change in patients' severity of obsessive and compulsive symptoms as measured with YBOCS 24 hours after ketamine infusion compared to midazolam infusion.	in each arm 24 hours after infusion
Secondary	Change of OCD symptoms (OCD-VAS)	There will be a change of symptoms over the course of seven days after ketamine infusion compared to midazolam infusion as measured with OCD-VAS area under the curves.	in each arm 1 week after the infusion
Secondary	Change in neuropsychological function	There will be a change in neuropsychological function after 24 hours after ketamine infusion compared to midazolam infusion as measured by four neurocognitive tests (N-Back, WCST, SSRT, ToH)	in each arm 24 hours after infusion
Secondary	Change in cortisol response	There will be a change in cortisol response to stress 24 hours after ketamine infusion compared to midazolam infusion.	in each arm 24 hours after infusion
Secondary	Change of vegetative stress response (cardiovascular)	There will be a change of vegetative stress response 24 hours after ketamine infusion compared to midazolam infusion as measured with cardiovascular parameters (HR, BP).	in each arm 24 hours after infusion
Secondary	Change of vegetative stress response (stress VAS)	There will be a change of vegetative stress response 24 hours after ketamine infusion compared to midazolam infusion as measured with subjective stress VAS.	in each arm 24 hours after infusion