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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01371110
Recruitment Status : Terminated (no funding)
First Posted : June 10, 2011
Results First Posted : October 2, 2017
Last Update Posted : January 18, 2018
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Wayne Goodman MD, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: Ketamine Drug: Midazolam Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Study Start Date : June 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: Ketamine
Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride
Drug: Ketamine
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.
Other Name: ketamine hydrochloride

Sham Comparator: Midazolam
Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam
Drug: Midazolam
Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.

Primary Outcome Measures :
  1. Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration [ Time Frame: Baseline and 24 Hours ]

    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 :
  1. Percentage of Patients Who Meet Response and Remission [ Time Frame: up to 14 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01371110

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United States, New York
Clinical Research Centers at Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Wayne Goodman MD
Icahn School of Medicine at Mount Sinai
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Principal Investigator: Wayne K Goodman, MD Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai)
Principal Investigator: Kyle Lapidus, MD (previously Icahn School of Medicine at Mount Sinai)
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Responsible Party: Wayne Goodman MD, Professor & Chair Psychiatry, Baylor College of Medicine Identifier: NCT01371110    
Other Study ID Numbers: GCO 11-1113
HSM#11-01536 ( Other Identifier: THE MOUNT SINAI HEALTH SYSTEM )
First Posted: June 10, 2011    Key Record Dates
Results First Posted: October 2, 2017
Last Update Posted: January 18, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wayne Goodman MD, Baylor College of Medicine:
Obsessive-Compulsive Disorder
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents