Ketamine and Stress in OCD

Ketamine

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.

Intervention / Treatment

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).
  • Ketamine 50 MG/ML (DRUG)
    See also Arm description
  • Midazolam (DRUG)
    See also Arm description

Condition or Disease

  • Obsessive-Compulsive Disorder
  • Psychiatric Disorder

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Enrollment: 30 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Aug 01, 2022 ACTUAL
    Primary Completion: Jun 01, 2023 ESTIMATED
    Completion Date: Jun 01, 2023 ESTIMATED
    Study First Posted: Oct 13, 2022 ACTUAL
    Last Updated: Oct 10, 2022

    Sponsors / Collaborators

    Lead Sponsor: Medical University of Vienna
    Responsible Party: N/A

    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.

    Participant Groups

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

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    Primary Outcomes

    • 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 Outcomes

    • 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.

    • 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.

    • 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.

    • 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)

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

    • 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).

    • There will be a change of vegetative stress response 24 hours after ketamine infusion compared to midazolam infusion as measured with subjective stress VAS.

    More Details

    NCT Number: NCT05577585
    Other IDs: v3 09.02.2022
    Study URL: https://clinicaltrials.gov/study/NCT05577585
    Last updated: Sep 29, 2023