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NCT Number: NCT05577585

Ketamine in OCD: Efficacy and Effects on Stress and Cognition

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Psychiatric Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, Department of Psychiatry and Psychotherapy

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Christoph Kraus, MD PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine 50 MG/ML Blinded

Drug

See also Arm description

Other names: Randomized Controlled Phase Intervention 1

midazolam

Drug

See also Arm description

Other names: Randomized Controlled Phase Intervention 2

Ketamine 50 MG/ML Open Label

Drug

Open Label Follow Up (up to 8 Infusions)

Other names: Continuation Phase Intervention 1

Treatment as usual (TAU)

Other

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.

Other names: Continuation Phase Intervention 2

Primary outcomes

  1. Change of OCD symptoms (Y-BOCS)

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

    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).

Secondary outcomes

  1. Change of OCD symptoms (OCD-VAS)

    Time frame: in each arm 24 hours after infusion

    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.

  2. Change of OCD symptoms (Y-BOCS)

    Time frame: in each arm 24 hours after infusion

    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.

  3. Change of OCD symptoms (OCD-VAS)

    Time frame: in each arm 1 week after the infusion

    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.

  4. Change in neuropsychological function

    Time frame: in each arm 24 hours after infusion

    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)

  5. Change in cortisol response

    Time frame: in each arm 24 hours after infusion

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

  6. Change of vegetative stress response (heart rate)

    Time frame: in each arm 24 hours after infusion

    There will be a change of vegetative stress response 24 hours after ketamine infusion compared to midazolam infusion as measured by heart rate.

  7. Change of vegetative stress response (blood pressure)

    Time frame: in each arm 24 hours after infusion

    There will be a change of vegetative stress response 24 hours after ketamine infusion compared to midazolam infusion as measured by blood pressure.

  8. Change of vegetative stress response (stress VAS)

    Time frame: in each arm 24 hours after infusion

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

  9. Change in OCD symptoms (OCD-VAS)

    Time frame: One month after start of open-label treatment

    Difference of the Obsessive-Compulsive Disorder Visual Analog Scale (OCD-VAS; score range 0-600, with higher scores indicating greater severity) scores a month after open-label treatment compared to treatment as usual, tested in a per protocol set.

  10. Change in OCD symptoms (YBOCS)

    Time frame: One month after start of open-label treatment

    Difference of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS; score range 0-40, with higher scores indicating greater severity) scores a month after open-label treatment compared to treatment as usual, tested in a per protocol set.

  11. Changes in EEG frequency bands

    Time frame: EEG measurements will take place before (5 minutes resting state EEG) and during both infusions of the blinded phase as well as after the open label phase (10 minutes resting state and 5 minutes vigilance EEG).

    There will be distinct changes in EEG frequency bands during ketamine infusion compared to midazolam. EEG will be recorded using a standard 32-channel montage. The following frequency bands will be analyzed at each channel: Delta (0.5-4 Hz), Theta (4-8 Hz), Alpha (8-13 Hz), Beta (13-30 Hz), and Gamma (>30 Hz).

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Kraus, MD PhD

CONTACT

[email protected]

+4314040035680

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: KET-OCD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2022
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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