120 Participants Needed

Ketamine for Obsessive-Compulsive Disorder

(MKET Trial)

EM
Overseen ByElizabeth McCarthy
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how ketamine quickly improves symptoms in people with Obsessive-Compulsive Disorder (OCD). Ketamine works by blocking a specific brain receptor, which helps reduce repetitive thoughts and behaviors. Recent research demonstrated that ketamine rapidly reduces OCD symptoms. The study focuses on how this process happens at different levels in the brain.

Will I have to stop taking my current medications?

The trial may require you to stop taking certain medications, especially if they could interact with ketamine or increase the risk of participation. The protocol mentions a treatment-free period, which suggests you might need to stop some medications temporarily.

How does the drug ketamine differ from other treatments for obsessive-compulsive disorder?

Ketamine is unique because it acts quickly and targets glutamate, a brain chemical involved in OCD, unlike traditional treatments that often take longer to work and focus on serotonin. It is administered as an infusion, which is different from the usual oral medications.12345

What evidence supports the effectiveness of ketamine for treating obsessive-compulsive disorder?

Research shows that ketamine, known for its rapid antidepressant effects, may have potential anti-compulsive effects. In a study, S-ketamine reduced marble-burying behavior, a model for obsessive-compulsive disorder, suggesting it might help with OCD symptoms.12567

Who Is on the Research Team?

Carolyn Rodriguez | Stanford Medicine

Carolyn Rodriguez, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a primary diagnosis of OCD who can give informed consent. Participants should have severe enough OCD symptoms to warrant the study and be able to go without other treatments for a while.

Inclusion Criteria

I can go without treatment for a while.
I understand and can agree to the study's procedures and risks.
My OCD symptoms are severe.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of either ketamine or midazolam

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine
  • Midazolam
Trial Overview The study aims to understand how Ketamine, compared with Midazolam, can rapidly alleviate symptoms of OCD. Patients will receive one of these drugs and their effects on OCD improvement will be closely monitored.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: KetamineExperimental Treatment1 Intervention
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
Group II: MidazolamActive Control1 Intervention
OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion

Ketamine is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Ketalar for:
  • Anesthesia
  • Treatment-resistant depression
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Approved in European Union as Ketalar for:
  • Anesthesia
  • Treatment-resistant depression
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Approved in United States as Spravato for:
  • Treatment-resistant depression
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Approved in European Union as Spravato for:
  • Treatment-resistant depression
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Approved in Canada as Spravato for:
  • Treatment-resistant depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

University of Connecticut

Collaborator

Trials
194
Recruited
162,000+

Published Research Related to This Trial

Ketamine, while effective as a rapid antidepressant in treatment-resistant depression, showed no sustained benefits for obsessive-compulsive disorder (OCD) in a small trial of 10 subjects, with only some experiencing acute antidepressant effects.
Concerns arose regarding delayed-onset dysphoria and increased anxiety or suicidal thoughts in patients with OCD and other psychiatric issues, highlighting the need for caution and further research before using ketamine off-label in such cases.
Two cases of delayed-onset suicidal ideation, dysphoria and anxiety after ketamine infusion in patients with obsessive-compulsive disorder and a history of major depressive disorder.Niciu, MJ., Grunschel, BD., Corlett, PR., et al.[2022]
In a trial involving 10 subjects with treatment-refractory OCD, ketamine infusion did not lead to significant improvements in OCD symptoms within the first 3 days, with less than 12% reduction observed.
However, 4 out of 7 patients with comorbid depression did show a rapid antidepressant response, indicating that while ketamine may help with depression, its effects on OCD symptoms were minimal and did not persist after the initial treatment.
Effects of ketamine in treatment-refractory obsessive-compulsive disorder.Bloch, MH., Wasylink, S., Landeros-Weisenberger, A., et al.[2021]
Oral S-ketamine was successfully used as a maintenance treatment for a patient with severe depression who did not respond to electroconvulsive therapy and deep brain stimulation, highlighting its potential efficacy in treatment-resistant cases.
The patient also had comorbid psychotic and obsessive-compulsive symptoms, suggesting that S-ketamine may be beneficial for individuals with complex mental health issues.
Oral S-ketamine effective after deep brain stimulation in severe treatment-resistant depression and extensive comorbidities.Veraart, JKE., Kamphuis, J., Schlegel, M., et al.[2021]

Citations

Two cases of delayed-onset suicidal ideation, dysphoria and anxiety after ketamine infusion in patients with obsessive-compulsive disorder and a history of major depressive disorder. [2022]
Effects of ketamine in treatment-refractory obsessive-compulsive disorder. [2021]
Oral S-ketamine effective after deep brain stimulation in severe treatment-resistant depression and extensive comorbidities. [2021]
S-ketamine reduces marble burying behaviour: Involvement of ventromedial orbitofrontal cortex and AMPA receptors. [2019]
Oral Ketamine for Depression, 1: Pharmacologic Considerations and Clinical Evidence. [2019]
Therapeutic Potentials of Ketamine and Esketamine in Obsessive-Compulsive Disorder (OCD), Substance Use Disorders (SUD) and Eating Disorders (ED): A Review of the Current Literature. [2021]
Efficacy of N-Acetylcysteine Augmentation on Obsessive Compulsive Disorder: A Multicenter Randomized Double Blind Placebo Controlled Clinical Trial. [2020]
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