Ketamine for Obsessive-compulsive disorder

Inclusion criteria

• {"criterion_text":"- Primary diagnosis of obsessive-compulsive disorder\n- A score of 16 or higher on the Yale-Brown Obsessive- Compulsive Scale\n- Age of at least 18 years and ability to provide written informed consent\n- At least one previous treatment for OCD"}

Exclusion criteria

• {"criterion_text":"- Any history of current or past psychotic disorder\n- Untreated hyperthyroidism\n- Untreated disorders severely affecting the HPA-axis (M.Addison, M.Cushing)\n- Current pharmacological therapy severely affecting the HPA- axis like corticosteroids or ACTH\n- Inability to follow the study protocol or adhere to operational requirements\n- A manic episode within the preceding three years\n- Current or unstable remitted substance abuse or dependence except nicotine\n- Pregnancy or elevated risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception\n- Any current severe personality disorder except comorbid anankastic personality disorder\n- Current unstable suicidality\n- Morbus Raynaud\n- Unstable hypertension\n- Any other severe and unstable cardiovascular disease -"}

Primary endpoints

• {"endpoint_text":"- Difference of changes in YBOCS scores before and 7 days after ketamine infusion compared midazolam infusion, tested in an intention to treat set.","definition_or_measurement_approach":"Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) score from baseline to 7 days after infusion; comparison between ketamine and midazolam arms; analysed in an intention-to-treat set."}

Secondary endpoints

• {"endpoint_text":"- Difference of changes in OCD-VAS scores between period specific baseline and 24h after ketamine infusion compared to midazolam infusion, tested in a per protocol set.","definition_or_measurement_approach":"Change in OCD visual analogue scale (OCD-VAS) from period-specific baseline to 24 hours post-infusion; comparison ketamine vs midazolam; analysed in per-protocol set."}
• {"endpoint_text":"- Difference of changes in YBOCS scores between period specific baseline and 24h after ketamine infusion compared to midazolam infusion, tested in a per protocol set.","definition_or_measurement_approach":"Change in YBOCS from period-specific baseline to 24 hours post-infusion; comparison ketamine vs midazolam; analysed in per-protocol set."}
• {"endpoint_text":"- Difference between areas under the curve of OCD-VAS, over the course of 7 days, starting with ketamine and midazolam infusion, respectively, tested in a per protocol set. 5)","definition_or_measurement_approach":"Area under the curve (AUC) of OCD-VAS over 7 days for each period (ketamine and midazolam); between-period comparison; analysed in per-protocol set."}
• {"endpoint_text":"- Difference of changes in neuropsychological function under stress between baseline and 24 hours post ketamine and midazolam infusion, respectively, measured by WCST, SSRT, N-back and ToH, tested in a per protocol set.","definition_or_measurement_approach":"Neuropsychological tests (WCST, SSRT, N-back, Tower of Hanoi) measured at baseline and 24 hours post-infusion; change scores compared between ketamine and midazolam; per-protocol analysis."}
• {"endpoint_text":"- Difference of changes of hormonal stress response between study baseline and 24 hours post ketamine compared to midazolam infusion, measured by salivary cortisol levels, summarized as an AUC for each period, tested in a per protocol set.","definition_or_measurement_approach":"Salivary cortisol levels measured over each period; summarized as AUC per period; comparison of AUCs ketamine vs midazolam; per-protocol analysis."}
• {"endpoint_text":"- Difference of changes of vegetative stress response between study baseline and 24 hours post ketamine compared to midazolam infusion, measured by blood pressure, heart rate and subjective stress VAS scores, summarized as an AUC for each period, tested in a per protocol set.","definition_or_measurement_approach":"Blood pressure, heart rate and subjective stress VAS measured and summarized as AUC per period; comparison between ketamine and midazolam; per-protocol analysis."}
• {"endpoint_text":"- Difference of OCD-VAS scores a month after open-label treatment compared to treatment as usual, tested in a per protocol set.","definition_or_measurement_approach":"OCD-VAS measured one month after open-label treatment vs treatment-as-usual group; per-protocol analysis."}
• {"endpoint_text":"- Difference of YBOCS scores a month after open-label treatment compared to treatment as usual, tested in a per protocol set.","definition_or_measurement_approach":"YBOCS measured one month after open-label treatment vs treatment-as-usual group; per-protocol analysis."}
• {"endpoint_text":"- Distinct changes in EEG frequency bands during ketamine infusion compared to midazolam.","definition_or_measurement_approach":"EEG frequency band changes recorded during infusion; comparison of patterns between ketamine and midazolam infusions."}

Austria

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

03-06-2025

Processing Time Days

246

Number Of Sites

1

Number Of Participants

66

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria