Clinical trial NCT05577585: Ketamine and Stress in OCD
Official title: Ketamine Therapy in Obsessive-compulsive Disorder and Its Effects on Neuropsychological Function Under Stress in a Cross-over Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Psychiatric Disorder
Keywords: Ketamine
stress testing
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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:

* 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

Primary outcomes:
measure: Change of OCD symptoms (Y-BOCS)
timeFrame: In total 7 YBOCS assessments will take place between week 1 and 5.
Secondary outcomes:
measure: Change of OCD symptoms (OCD-VAS)
timeFrame: in each arm 24 hours after infusion
measure: Change of OCD symptoms (Y-BOCS)
timeFrame: in each arm 24 hours after infusion
measure: Change of OCD symptoms (OCD-VAS)
timeFrame: in each arm 1 week after the infusion
measure: Change in neuropsychological function
timeFrame: in each arm 24 hours after infusion
measure: Change in cortisol response
timeFrame: in each arm 24 hours after infusion
measure: Change of vegetative stress response (cardiovascular)
timeFrame: in each arm 24 hours after infusion
measure: Change of vegetative stress response (stress VAS)
timeFrame: in each arm 24 hours after infusion
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Psychiatry and Psychotherapy
Study officials:
affiliation: Medical University of Vienna, Department of Psychiatry and Psychotherapy
name: Christoph Kraus, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: