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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine 50 MG/ML Blinded | Drug | See also Arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | In total 7 YBOCS assessments will take place between week 1 and 5. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | in each arm 24 hours after infusion |
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Inclusion Criteria:
Exclusion Criteria Experimental Group:
Exclusion Criteria Treatment as Usual Group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Kraus, MD PhD | Contact | +4314040035680 | christoph.kraus@muv.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Kraus, MD PhD | Medical University of Vienna, Department of Psychiatry and Psychotherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Department of Psychiatry and Psychotherapy | Recruiting | Vienna | State of Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008874 | Midazolam |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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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.
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| Midazolam | Drug | See also Arm description |
|
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| Ketamine 50 MG/ML Open Label | Drug | Open Label Follow Up (up to 8 Infusions) |
|
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| 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. |
|
|
| 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. | 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. | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |