Ketamine and Stress in OCD
- Conditions
- Obsessive-Compulsive DisorderPsychiatric Disorder
- Interventions
- Registration Number
- NCT05577585
- Lead Sponsor
- Medical University of Vienna
- Brief 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.
- 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ketamine Ketamine 50 MG/ML 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. Midazolam Midazolam 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.
- Primary Outcome Measures
Name Time Method Change of OCD symptoms (Y-BOCS) 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 Y-BOCS.
- Secondary Outcome Measures
Name Time Method Change in neuropsychological function 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)
Change of OCD symptoms (Y-BOCS) in each arm 24 hours after infusion There will be a change in patients' severity of obsessive and compulsive symptoms as measured with YBOCS 24 hours after ketamine infusion compared to midazolam infusion.
Change in cortisol response 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.
Change of vegetative stress response (cardiovascular) 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 cardiovascular parameters (HR, BP).
Change of vegetative stress response (stress VAS) 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.
Change of OCD symptoms (OCD-VAS) 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 OCD-VAS area under the curves.
Trial Locations
- Locations (1)
Medical University of Vienna, Department of Psychiatry and Psychotherapy
🇦🇹Vienna, Austria