Understanding How Ketamine Brings About Rapid Improvement in OCD (MKET)

Stanford University

Status and phase: Active, not recruiting; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Ketamine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT02624596

34622

Details and patient eligibility

About

The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.

Full description

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to build on our discovery that a potent NMDA receptor antagonist, ketamine, has rapid (in hours) and robust therapeutic effects in OCD. The proposed projects test the acute mechanism of action of ketamine at the level of molecules, circuits, and network synchrony to determine how NMDA receptor antagonism modifies the underlying pathology of OCD to relieve repetitive thoughts and behaviors.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for participants with OCD:

• age 18-65
• Primary diagnosis of OCD
• Sufficient severity of OCD symptoms
• ability to tolerate a treatment-free period
• capacity to provide informed consent

Inclusion criteria for healthy controls:

• ages 18-65
• capacity to provide informed consent

Exclusion criteria for participants with OCD:

• Psychiatric or medical conditions that make participation unsafe
• pregnant or nursing females
• concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
• presence of metallic device or dental braces

Exclusion criteria for healthy controls:

• any current or lifetime psychiatric diagnosis
• pregnant or nursing females
• major medical or neurological problem
• presence of metallic device or dental braces

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Ketamine

Experimental group

Description:

OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion

Treatment:

Drug: Ketamine

Midazolam

Active Comparator group

Description:

OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion

Treatment:

Drug: Midazolam