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Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder (IVKetamine)

Primary Purpose

Obsessive Compulsive Disorder

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ketamine

Midazolam

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring OCD, Obsessive-Compulsive Disorder, ketamine, treatment

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients, 21-65 years
Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
Primary diagnosis of Obsessive-Compulsive Disorder as assessed by the SCID-P, with symptoms for at least 1 year (Patients who meet criteria for OCD will be required to be medication free or have all psychotropics aside from SSRIs and as needed benzodiazepines tapered. Prior to study entry, proscribed psychotropics are tapered, and subjects must be on the same SSRI for at least 8 weeks with no change in dose for at least 4 weeks and throughout the study. However, subjects will be allowed to use benzodiazepines as needed throughout the study.)
History of a failure to respond to at least two (2) adequate pharmacotherapy trials and CBT for OCD
Subjects must have scored ≥ 21 on the Y-BOCS at Screening, and to not be in remission on Treatment Day #1, and Treatment Day #2
Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria:

Women who plan to become pregnant within the next six months, are pregnant or are breast-feeding
Non-English speakers
Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG
Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, or pervasive developmental disorders
Current evidence of psychotic or manic symptoms
Drug or alcohol abuse or dependence within the preceding 6 months
Lifetime abuse or dependence on ketamine or phencyclidine
Patients judged by study investigator to be at high risk for suicide
Current use of psychotropics other than SSRIs

Sites / Locations

Clinical Research Centers at Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ketamine

Midazolam

Arm Description

Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride

Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam

Outcomes

Primary Outcome Measures

Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration

The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine. The 10 Y-BOCCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme.

Secondary Outcome Measures

Percentage of Patients Who Meet Response and Remission

Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days.

Full Information

NCT ID

NCT01371110

First Posted

June 7, 2011

Last Updated

January 16, 2018

Sponsor

Wayne Goodman MD

Collaborators

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT01371110

Brief Title

Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder

Acronym

IVKetamine

Official Title

Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Terminated

Why Stopped

no funding

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wayne Goodman MD

Collaborators

Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading cause of worldwide disability that presents a significant public health problem. Treatment options are limited and many OCD patients fail to respond completely or quickly to standard treatments, including pharmacotherapy and psychotherapy. At this time, patients who fail to respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and behavioral therapy, have few additional treatment options aside from deep brain stimulation. Therefore, despite advances in current pharmacological and behavioral treatments, and the utility of serotonergic drugs, it is likely that other neurotransmitter systems are involved and that targeting these systems may increase treatment efficacy. Despite little evidence for serotonergic dysfunction in OCD, there is significant evidence that glutamatergic dysregulation may contribute to the development and progression of the disorder. Also, preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine), particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single intravenous (IV) dose in depressed patients. Therefore, the objective of the current study is to investigate the safety and efficacy of a single dose of IV ketamine in treatment-resistant OCD.

Detailed Description

This study will test the safety and efficacy of a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, ketamine, in treatment-resistant OCD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive Compulsive Disorder

Keywords

OCD, Obsessive-Compulsive Disorder, ketamine, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Active Comparator

Arm Description

Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride

Arm Title

Midazolam

Arm Type

Sham Comparator

Arm Description

Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam

Intervention Type

Drug

Intervention Name(s)

Ketamine

Other Intervention Name(s)

ketamine hydrochloride

Intervention Description

Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.

Intervention Type

Drug

Intervention Name(s)

Midazolam

Intervention Description

Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.

Primary Outcome Measure Information:

Title

Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration

Description

Time Frame

Baseline and 24 Hours

Secondary Outcome Measure Information:

Title

Percentage of Patients Who Meet Response and Remission

Description

Time Frame

up to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients, 21-65 years Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study Primary diagnosis of Obsessive-Compulsive Disorder as assessed by the SCID-P, with symptoms for at least 1 year (Patients who meet criteria for OCD will be required to be medication free or have all psychotropics aside from SSRIs and as needed benzodiazepines tapered. Prior to study entry, proscribed psychotropics are tapered, and subjects must be on the same SSRI for at least 8 weeks with no change in dose for at least 4 weeks and throughout the study. However, subjects will be allowed to use benzodiazepines as needed throughout the study.) History of a failure to respond to at least two (2) adequate pharmacotherapy trials and CBT for OCD Subjects must have scored ≥ 21 on the Y-BOCS at Screening, and to not be in remission on Treatment Day #1, and Treatment Day #2 Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact. Exclusion Criteria: Women who plan to become pregnant within the next six months, are pregnant or are breast-feeding Non-English speakers Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, or pervasive developmental disorders Current evidence of psychotic or manic symptoms Drug or alcohol abuse or dependence within the preceding 6 months Lifetime abuse or dependence on ketamine or phencyclidine Patients judged by study investigator to be at high risk for suicide Current use of psychotropics other than SSRIs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wayne K Goodman, MD

Organizational Affiliation

Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kyle Lapidus, MD

Organizational Affiliation

(previously Icahn School of Medicine at Mount Sinai)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Centers at Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

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Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder

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