Back to results

Ketamine and Stress in OCD (KET-OCD)

Primary Purpose

Obsessive-Compulsive Disorder, Psychiatric Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Ketamine 50 MG/ML

Midazolam

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Ketamine, stress testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of Vienna, Department of Psychiatry and PsychotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine

Midazolam

Arm Description

Participants will undergo one infusion of ketamine as active comparator. (R,S-ketamine 50mg/ml solution for injection, dose: 0,5 mg per kg bodyweight) Both medications will be diluted in 100 ml saline and will be adjusted for infusion over 40 minutes, administered with a syringe pump.

Participants will undergo one infusion of midazolam as comparator. (0,045 mg/kg bodyweight) Both medications will be diluted in 100 ml saline and will be adjusted for infusion over 40 minutes, administered with a syringe pump.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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)

Change in cortisol response

There will be a change in cortisol response to stress 24 hours after ketamine infusion compared to midazolam infusion.

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).

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.

Full Information

NCT ID

NCT05577585

First Posted

September 25, 2022

Last Updated

October 10, 2022

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT05577585

Brief Title

Ketamine and Stress in OCD

Acronym

KET-OCD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder, Psychiatric Disorder

Keywords

Ketamine, stress testing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This study will apply a randomized, double blind, comparator-controlled cross-over design. The order of treatment modality will be randomized and double-blind. Participants will undergo one infusion of ketamine and midazolam as comparator. They will be assigned to one of two sequenced treatment groups, with one group first receiving verum and after 14 days the comparator infusion, the other group vice versa. The randomization into these two sequence groups will be stratified for symptom severity, defined as moderate (YBOCS baseline >16) or severe (YBOCS baseline >25).

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Active Comparator

Arm Description

Arm Title

Midazolam

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ketamine 50 MG/ML

Intervention Description

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Kraus, MD PhD

Phone

+4314040035680

christoph.kraus@muv.ac.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Kraus, MD PhD

Organizational Affiliation

Medical University of Vienna, Department of Psychiatry and Psychotherapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna, Department of Psychiatry and Psychotherapy

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christoph Kraus, MD PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ketamine and Stress in OCD

We'll reach out to this number within 24 hrs