Understanding How Ketamine Brings About Rapid Improvement in OCD

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2026-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

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

Midazolam

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

Interventions

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Ketamine

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

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

Other Intervention Names

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Ketamine Hydrochloride Midazolam Hydrochloride

Eligibility Criteria

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Inclusion Criteria

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

* ages 18-65
* capacity to provide informed consent

Exclusion Criteria

* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes