Study on Ketamine and Midazolam for Treating Obsessive-Compulsive Disorder in Adults

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What is this study about?

This clinical trial is focused on studying the effects of Ketamine therapy in individuals with Obsessive-Compulsive Disorder (OCD). The study aims to test how effective Ketamine is in treating OCD symptoms. Participants will receive Ketamine through an infusion, which is a method of delivering medication directly into the bloodstream. The study will also use Midazolam, known by its code names TAK-815 and SHP-615, as a comparison treatment. Midazolam is also administered via infusion.

The trial will follow a cross-over design, meaning participants will receive both treatments at different times. The effects of Ketamine on OCD symptoms will be compared to those of Midazolam. The study will also look at how these treatments affect neuropsychological functions, which are brain functions related to thinking and behavior, especially under stress. Participants will be monitored for changes in their OCD symptoms and stress responses, including hormonal and physical reactions, over a period of time.

The primary goal is to observe any differences in OCD symptoms before and after receiving Ketamine compared to Midazolam. Secondary observations will include changes in stress levels and neuropsychological functions. The study will help understand the potential benefits of Ketamine for people with OCD and how it might improve their quality of life by reducing symptoms and stress-related effects.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying a primary diagnosis of obsessive-compulsive disorder (OCD) and a score of 16 or higher on the Yale-Brown Obsessive-Compulsive Scale. Participants must be at least 18 years old and able to provide written informed consent. A history of at least one previous treatment for OCD is required.

2 baseline measurements

Baseline measurements will be taken to assess current OCD symptoms and stress responses. This includes completing questionnaires and possibly providing saliva samples to measure cortisol levels, which indicate stress.

3 first infusion session

Participants will receive an infusion of either ketamine or midazolam. Ketamine is administered as a 50 mg/ml solution, while midazolam is given as a 5 mg/ml solution. The infusion will be monitored closely by medical staff.

4 post-infusion assessment

After the infusion, participants will undergo assessments to measure changes in OCD symptoms and stress responses. This includes completing questionnaires and providing additional saliva samples 24 hours after the infusion.

5 second infusion session

Participants will receive the second infusion, which will be the opposite treatment from the first session (either ketamine or midazolam). This is part of the cross-over design of the study.

6 final assessment

A final assessment will be conducted to evaluate the overall effects of the treatments. This includes measuring OCD symptoms and stress responses one month after the open-label treatment phase.

Who Can Join the Study?

Have a primary diagnosis of obsessive-compulsive disorder (OCD). This means OCD is the main condition you have been diagnosed with.
Have a score of 16 or higher on the Yale-Brown Obsessive-Compulsive Scale. This is a questionnaire used to measure the severity of OCD symptoms.
Be at least 18 years old and able to provide written informed consent. This means you understand the study and agree to participate by signing a form.
Have had at least one previous treatment for OCD. This means you have tried some form of treatment for OCD before joining this study.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to ketamine or any of its components cannot participate. Ketamine is a medication used in this study.
Individuals with uncontrolled high blood pressure are excluded. High blood pressure means the force of blood against your artery walls is too high.
People with a history of severe heart disease cannot join. Heart disease refers to various types of heart conditions.
Participants with a history of severe mental health disorders, other than Obsessive Compulsive Disorder (OCD), are not eligible. OCD is a condition where people have recurring, unwanted thoughts, ideas, or sensations that make them feel driven to do something repetitively.
Pregnant or breastfeeding women are not allowed to participate.
Individuals currently participating in another clinical trial are excluded.
Patients with a history of substance abuse or addiction are not eligible. Substance abuse refers to the harmful or hazardous use of psychoactive substances, including alcohol and illicit drugs.
Anyone with a significant medical condition that the study doctors believe would make participation unsafe is excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	13.11.2024

Trial locations

Investigated drugs:

Ketamine is a medication that is being tested in this trial for its potential benefits in treating obsessive-compulsive disorder (OCD). It is known for its ability to quickly relieve symptoms of depression and anxiety in some people. In this study, researchers are exploring whether ketamine can help reduce the symptoms of OCD and improve how the brain functions under stress. Ketamine is usually given as an infusion, which means it is administered directly into the bloodstream through a vein. The goal is to see if ketamine can provide relief from OCD symptoms and improve mental health.

Investigated diseases:

Obsessive-compulsive disorder

Obsessive Compulsive Disorder (OCD) – Obsessive Compulsive Disorder is a mental health condition characterized by persistent, unwanted thoughts (obsessions) and repetitive behaviors or mental acts (compulsions) that an individual feels driven to perform. These obsessions and compulsions can significantly interfere with daily activities and social interactions. The disorder often begins in childhood or adolescence and can progress in severity over time. Individuals with OCD may experience cycles of symptom intensity, with periods of increased stress often exacerbating the condition. The compulsive behaviors are typically performed in an attempt to reduce anxiety or prevent a feared event or situation, although they are not connected in a realistic way to what they are intended to prevent. Over time, the compulsions can become more time-consuming and distressing, impacting the individual’s quality of life.

Trial ID:

2024-518212-40-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ketamine and Midazolam for Treating Obsessive-Compulsive Disorder in Adults

What is this study about?

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Who Cannot Join the Study?