DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017