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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01100255
First received: April 5, 2010
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Obsessive-Compulsive Disorder
Drug: Ketamine infusion
Other: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Improvement in severity of Obsessive Compulsive Disorder symptoms as measured by the Yale-Brown Obsessive Compulsive Scale. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline infusion
IV saline infusion over 40 minutes
Other: Saline
saline infusion
Experimental: Ketamine Infusion
0.5mg/kg IV infusion over 40 minutes
Drug: Ketamine infusion
0.5mg/kg IV over 40 minutes
Other Name: Ketamine hydrochloride

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100255

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

No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01100255     History of Changes
Other Study ID Numbers: 6906R/5883
Study First Received: April 5, 2010
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
OCD

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Disease
Personality Disorders
Mental Disorders
Anxiety Disorders
Pathologic Processes
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 22, 2014