Ketamine and Stress in OCD

Last updated: April 25, 2024
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obsessive-compulsive Disorder

Kleptomania

Panic Disorders

Treatment

Midazolam

Ketamine 50 MG/ML

Clinical Study ID

NCT05577585
v3 09.02.2022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 havechildren) and refusal to utilize a proper method of contraception
  • Any current severe personality disorder except comorbid anankastic personalitydisorder
  • 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 corticosteroidsor ACTH

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Midazolam
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Medical University of Vienna, Department of Psychiatry and Psychotherapy

    Vienna, 1090
    Austria

    Active - Recruiting

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