Ketamine in OCD: Efficacy and Effects on Stress and Cognition

Medical University of Vienna60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obsessive-Compulsive Disorder Psychiatric Disorder

Interventions

Ketamine 50 MG/ML BlindedDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Experimental Group: * 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 Exclusion Criteria Treatment as Usual Group: * 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 * Any current severe personality disorder except comorbid anankastic personality disorder * Current and unstable suicidality

Locations (1)

Medical University of Vienna, Department of Psychiatry and Psychotherapy

Vienna, Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

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 the Yale-Brown Obsessive Compulsive Scale (Y-BOCS; score range 0-40, with higher scores indicating greater severity).

Time frame: In total 7 YBOCS assessments will take place between week 1 and 5.

Secondary Outcomes

Change of OCD symptoms (OCD-VAS)

There will be a change in patients' severity of obsessive and compulsive symptoms as measured with the Obsessive-Compulsive Disorder Visual Analog Scale (OCD-VAS; score range 0-600, with higher scores indicating greater severity) 24 hours after ketamine infusion compared to midazolam infusion.

Time frame: in each arm 24 hours after infusion

Change of OCD symptoms (Y-BOCS)

There will be a change in patients' severity of obsessive and compulsive symptoms as measured with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS; score range 0-40, with higher scores indicating greater severity) 24 hours after ketamine infusion compared to midazolam infusion.

Time frame: in each arm 24 hours after 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 the Obsessive-Compulsive Disorder Visual Analog Scale (OCD-VAS; score range 0-600, with higher scores indicating greater severity) area under the curves.

Time frame: in each arm 1 week after the infusion

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)

Central Contacts

Christoph Kraus, MD PhD

CONTACT

+4314040035680 christoph.kraus@muv.ac.at

Data from ClinicalTrials.gov

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