Ketamine in OCD: Efficacy and Effects on Stress and Cognition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obsessive-Compulsive Disorder Psychiatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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). The randomized cross-over phase is followed by an optional open-label continuation with 8 ketamine infusions. Open-label participants are compared to a treatment as usual group.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketamine

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.

Group Type ACTIVE_COMPARATOR

Ketamine 50 MG/ML Blinded

Intervention Type DRUG

See also Arm description

Ketamine 50 MG/ML Open Label

Intervention Type DRUG

Open Label Follow Up (up to 8 Infusions)

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.

Group Type PLACEBO_COMPARATOR

Midazolam

Intervention Type DRUG

See also Arm description

Treatment as Usual

Participants will receive standard-of-care treatment-which may include psychotherapy, pharmacotherapy, physiotherapy, ergotherapy, or a combination of these-at the discretion of the treating physician, independently of the study.

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type OTHER

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.

Interventions

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Ketamine 50 MG/ML Blinded

See also Arm description

Intervention Type DRUG

Midazolam

See also Arm description

Intervention Type DRUG

Ketamine 50 MG/ML Open Label

Open Label Follow Up (up to 8 Infusions)

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Randomized Controlled Phase Intervention 1 Randomized Controlled Phase Intervention 2 Continuation Phase Intervention 1 Continuation Phase Intervention 2

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No