Obsessive-Compulsive DisorderKET-OCDNCT05577585
Ketamine in OCD: Efficacy and Effects on Stress and Cognition
A study testing Ketamine 50 MG/ML Blinded, Midazolam and Ketamine 50 MG/ML Open Label in people with Obsessive-Compulsive Disorder and Psychiatric Disorder, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder, Psychiatric Disorder
- What is being tested?
- Ketamine 50 MG/ML Blinded, Midazolam and Ketamine 50 MG/ML Open Label
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Psychiatry and Psychotherapy
Vienna, State of Vienna, 1090
Christoph Kraus, MD PhD
About this study
Official title: Ketamine Therapy in Obsessive-compulsive Disorder and Its Effects on Neuropsychological Function Under Stress in a Cross-over Trial
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.
Read the detailed 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. 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.
- Being tested
- Ketamine 50 MG/ML Blinded, Midazolam, Ketamine 50 MG/ML Open Label, Treatment as Usual (TAU)
- Keywords
- Ketamine, stress testing
- Medical subject headings
- Obsessive-Compulsive Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 50 MG/ML BlindedDrug
Also called Randomized Controlled Phase Intervention 1
See also Arm description
MidazolamDrug
Also called Randomized Controlled Phase Intervention 2
See also Arm description
Ketamine 50 MG/ML Open LabelDrug
Also called Continuation Phase Intervention 1
Open Label Follow Up (up to 8 Infusions)
Also called Continuation Phase Intervention 2
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | 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. Receives: Drug: Ketamine 50 MG/ML Blinded; Drug: Ketamine 50 MG/ML Open Label |
| Midazolam | Placebo comparator | 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. Receives: Drug: Midazolam |
| Treatment as Usual | Active comparator | Participants will receive standard-of-care treatment-which may include psychotherapy, pharmacotherapy, physiotherapy, ergotherapy, or a combination of these-at the discretion of the treating physician, independently of the study. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of OCD symptoms (Y-BOCS)
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).
Measured: In total 7 YBOCS assessments will take place between week 1 and 5.
Secondary outcomes (11)
Change of OCD symptoms (OCD-VAS)
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.
Measured: in each arm 24 hours after infusion
Change of OCD symptoms (Y-BOCS)
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.
Measured: in each arm 24 hours after infusion
Change of OCD symptoms (OCD-VAS)
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.
Measured: in each arm 1 week after the infusion
Change in neuropsychological function
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)
Measured: in each arm 24 hours after infusion
Change in cortisol response
There will be a change in cortisol response to stress 24 hours after ketamine infusion compared to midazolam infusion.
Measured: in each arm 24 hours after infusion
Change of vegetative stress response (heart rate)
There will be a change of vegetative stress response 24 hours after ketamine infusion compared to midazolam infusion as measured by heart rate.
Measured: in each arm 24 hours after infusion
Change of vegetative stress response (blood pressure)
There will be a change of vegetative stress response 24 hours after ketamine infusion compared to midazolam infusion as measured by blood pressure.
Measured: in each arm 24 hours after infusion
Change of vegetative stress response (stress VAS)
There will be a change of vegetative stress response 24 hours after ketamine infusion compared to midazolam infusion as measured with subjective stress VAS.
Measured: in each arm 24 hours after infusion
Change in OCD symptoms (OCD-VAS)
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.
Measured: One month after start of open-label treatment
Change in OCD symptoms (YBOCS)
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.
Measured: One month after start of open-label treatment
Changes in EEG frequency bands
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Oct 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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). The randomized cross-over phase is followed by an optional open-label continuation with 8 ketamine infusions. Open-label participants are compared to a treatment as usual group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Kraus, Medical University of Vienna
- Investigators
- Christoph Kraus, MD PhD, Principal investigator, Medical University of Vienna, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577585
- Sponsor's protocol ID
- v6 05.05.2025
- Acronym
- KET-OCD
- Status last verified
- Jun 2025
- First submitted
- 25 Sep 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Therapy in Obsessive-compulsive Disorder and Its Effects on Neuropsychological Function Under Stress in a Cross-over Trial
- ClinicalTrials.gov ID
- NCT05577585
- Acronym / sponsor ID
- KET-OCD / v6 05.05.2025
- Keywords
- Ketamine, stress testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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). The randomized cross-over phase is followed by an optional open-label continuation with 8 ketamine infusions. Open-label participants are compared to a treatment as usual group.
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Ketamine 50 MG/ML Blinded, Drug: Ketamine 50 MG/ML Open LabelParticipants 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. |
| Midazolam | Placebo comparator | Drug: MidazolamParticipants 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. |
| Treatment as Usual | Active comparator | Other: Treatment as Usual (TAU)Participants will receive standard-of-care treatment-which may include psychotherapy, pharmacotherapy, physiotherapy, ergotherapy, or a combination of these-at the discretion of the treating physician, independently of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine 50 MG/ML BlindedAlso: Randomized Controlled Phase Intervention 1See also Arm description | Drug | Ketamine |
| MidazolamAlso: Randomized Controlled Phase Intervention 2See also Arm description | Drug | Midazolam |
| Ketamine 50 MG/ML Open LabelAlso: Continuation Phase Intervention 1Open Label Follow Up (up to 8 Infusions) | Drug | Ketamine |
| Treatment as Usual (TAU)Also: Continuation Phase Intervention 2Treatment 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 | Treatment as Usual |
Primary outcome
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).
11 secondary outcomes
Change of OCD symptoms (OCD-VAS)
Time frame: in each arm 24 hours after infusion
Change of OCD symptoms (Y-BOCS)
Time frame: in each arm 24 hours after infusion
Change of OCD symptoms (OCD-VAS)
Time frame: in each arm 1 week after the infusion
Change in neuropsychological function
Time frame: in each arm 24 hours after infusion
Change in cortisol response
Time frame: in each arm 24 hours after infusion
Change of vegetative stress response (heart rate)
Time frame: in each arm 24 hours after infusion
Change of vegetative stress response (blood pressure)
Time frame: in each arm 24 hours after infusion
Change of vegetative stress response (stress VAS)
Time frame: in each arm 24 hours after infusion
Change in OCD symptoms (OCD-VAS)
Time frame: One month after start of open-label treatment
Change in OCD symptoms (YBOCS)
Time frame: One month after start of open-label treatment
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Kraus, MD PhD principal investigator
Medical University of Vienna, Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine 50 MG/ML Blinded, Midazolam and Ketamine 50 MG/ML Open Label in people with Obsessive-Compulsive Disorder and Psychiatric Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph Kraus, MD PhD (+4314040035680, christoph.kraus@muv.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of OCD symptoms (Y-BOCS) (time frame: In total 7 YBOCS assessments will take place between week 1 and 5.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.