Ketamine in OCD: Efficacy and Effects on Stress and Cognition

Официальное название

Ketamine Therapy in Obsessive-compulsive Disorder and Its Effects on Neuropsychological Function Under Stress in a Cross-over Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ketamine 50 MG/ML Blinded
  See also Arm description
• Препарат Midazolam
  See also Arm description
• Препарат Ketamine 50 MG/ML Open Label
  Open Label Follow Up (up to 8 Infusions)
• Другое 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.

Первичные конечные точки

• Change of OCD symptoms (Y-BOCS) [Срок оценки: In total 7 YBOCS assessments will take place between week 1 and 5.]

Вторичные конечные точки (11)

• Change of OCD symptoms (OCD-VAS) [Срок оценки: in each arm 24 hours after infusion]
• Change of OCD symptoms (Y-BOCS) [Срок оценки: in each arm 24 hours after infusion]
• Change of OCD symptoms (OCD-VAS) [Срок оценки: in each arm 1 week after the infusion]
• Change in neuropsychological function [Срок оценки: in each arm 24 hours after infusion]
• Change in cortisol response [Срок оценки: in each arm 24 hours after infusion]
• Change of vegetative stress response (heart rate) [Срок оценки: in each arm 24 hours after infusion]
• Change of vegetative stress response (blood pressure) [Срок оценки: in each arm 24 hours after infusion]
• Change of vegetative stress response (stress VAS) [Срок оценки: in each arm 24 hours after infusion]
• Change in OCD symptoms (OCD-VAS) [Срок оценки: One month after start of open-label treatment]
• Change in OCD symptoms (YBOCS) [Срок оценки: One month after start of open-label treatment]
• Changes in EEG frequency bands [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Австрия · 1 центр

• Medical University of Vienna, Department of Psychiatry and Psychotherapy — Vienna

Идентификаторы

NCT: NCT05577585 · v6 05.05.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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