Ketamine in OCD: Efficacy and Effects on Stress and Cognition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine 50 MG/ML Blinded, Midazolam, Ketamine 50 MG/ML Open Label, Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: Obsessive-Compulsive Disorder, Psychiatric Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ketamine Therapy in Obsessive-compulsive Disorder and Its Effects on Neuropsychological Function Under Stress in a Cross-over Trial
Overview
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.
Interventions
- Drug Ketamine 50 MG/ML Blinded
See also Arm description - Drug Midazolam
See also Arm description - Drug Ketamine 50 MG/ML Open Label
Open Label Follow Up (up to 8 Infusions) - Other Treatment as Usual (TAU)
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.
Primary outcome measures
- Change of OCD symptoms (Y-BOCS) [Time frame: In total 7 YBOCS assessments will take place between week 1 and 5.]
Secondary outcome measures (11)
- 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Medical University of Vienna, Department of Psychiatry and Psychotherapy — Vienna
Identifiers
NCT: NCT05577585 · v6 05.05.2025