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Ketamine and Stress in OCD

Recruiting
18 years of age
Both
Phase N/A

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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.

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.

Eligibility

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

Study details

Obsessive-Compulsive Disorder, Psychiatric Disorder

NCT05577585

Medical University of Vienna

30 April 2024

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