Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)

• ClinicalTrials.gov Identifier: NCT01100255
• Recruitment Status: Completed
• First Posted: April 8, 2010
• Results First Posted: October 27, 2016
• Last Update Posted: February 20, 2017
• Sponsor: New York State Psychiatric Institute
• Information provided by (Responsible Party): New York State Psychiatric Institute

Study Description

Brief Summary:

In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).

Condition or disease	Intervention/treatment	Phase
Obsessive-Compulsive Disorder	Drug: Ketamine infusion; Other: Saline	Phase 2

Detailed Description:

Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug ketamine, which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate (NMDA), in a 2-week placebo controlled study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine
• Study Start Date: April 2010
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group A; 0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes	Drug: Ketamine infusion; 0.5mg/kg IV over 40 minutes; Other Name: Ketamine hydrochloride; Other: Saline; saline infusion
Active Comparator: Group B; IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes	Drug: Ketamine infusion; 0.5mg/kg IV over 40 minutes; Other Name: Ketamine hydrochloride; Other: Saline; saline infusion

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. [ Time Frame: 1 week ]
   Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age 18-55
• Physically healthy and not currently pregnant
• Primary Diagnosis of OCD
• Sufficient severity of symptoms
• Able to provide consent

Exclusion Criteria:

• Psychiatric conditions that make participation unsafe
• Currently on psychotropic medication
• Medical conditions that make participation unsafe
• Allergy to ketamine
• Any metal in the body

Contacts and Locations

Locations

United States, New York

New York State Psychiatric Institute

New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

• Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D.; Columbia-NYSPI-RFMH

More Information

Publications of Results:

Rodriguez CI, Kegeles LS, Flood P, Simpson HB. Rapid resolution of obsessions after an infusion of intravenous ketamine in a patient with treatment-resistant obsessive-compulsive disorder. J Clin Psychiatry. 2011 Apr;72(4):567-9. doi: 10.4088/JCP.10l06653. No abstract available.

Rodriguez CI, Kegeles LS, Levinson A, Feng T, Marcus SM, Vermes D, Flood P, Simpson HB. Randomized controlled crossover trial of ketamine in obsessive-compulsive disorder: proof-of-concept. Neuropsychopharmacology. 2013 Nov;38(12):2475-83. doi: 10.1038/npp.2013.150. Epub 2013 Jun 19.

Rodriguez CI, Kegeles LS, Levinson A, Ogden RT, Mao X, Milak MS, Vermes D, Xie S, Hunter L, Flood P, Moore H, Shungu DC, Simpson HB. In vivo effects of ketamine on glutamate-glutamine and gamma-aminobutyric acid in obsessive-compulsive disorder: Proof of concept. Psychiatry Res. 2015 Aug 30;233(2):141-7. doi: 10.1016/j.pscychresns.2015.06.001. Epub 2015 Jun 6.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01100255
• Other Study ID Numbers: 6906R/5883
• First Posted: April 8, 2010
• Results First Posted: October 27, 2016
• Last Update Posted: February 20, 2017
• Last Verified: January 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:

OCD

Additional relevant MeSH terms:

Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Personality Disorders; Mental Disorders; Anxiety Disorders; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action