RecruitingNot ApplicableNCT05577585

Ketamine in OCD: Efficacy and Effects on Stress and Cognition

Ketamine Therapy in Obsessive-compulsive Disorder and Its Effects on Neuropsychological Function Under Stress in a Cross-over Trial


Sponsor

Medical University of Vienna

Enrollment

60 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria18

  • 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
  • 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

Interventions

DRUGKetamine 50 MG/ML Blinded

See also Arm description

DRUGMidazolam

See also Arm description

DRUGKetamine 50 MG/ML Open Label

Open Label Follow Up (up to 8 Infusions)

OTHERTreatment as Usual (TAU)

Treatment as Usual may include psychotherapy, pharmacotherapy, physiotherapy, ergotherapy, or a combination of these-at the discretion of the treating physician, independently of the study.


Locations(1)

Medical University of Vienna, Department of Psychiatry and Psychotherapy

Vienna, Vienna, Austria

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NCT05577585


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