Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive Compulsive Disorder
Intervention: Ketamine (Drug); Midazolam (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Wayne Goodman Official(s) and/or principal investigator(s): Wayne K Goodman, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai Kyle Lapidus, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
Overall contact: Wayne K Goodman, MD, Phone: 212-659-8860, Email: wayne.goodman@mssm.edu
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.
Clinical Details
Official title: Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Y-BOCCS from baseline to 24-hours after ketamine administration
Secondary outcome: Percentage of patients who meet response and remission
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Wayne K Goodman, MD, Phone: 212-659-8860, Email: wayne.goodman@mssm.edu
Clinical Research Centers at Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States; Recruiting Wayne K Goodman, MD, Principal Investigator Kyle Lapidus, MD, Principal Investigator
Additional Information
Starting date: June 2012
Last updated: November 3, 2014
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