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

Tracking Information

• First Submitted Date: April 5, 2010
• First Posted Date: April 8, 2010
• Results First Submitted Date: May 19, 2016
• Results First Posted Date: October 27, 2016
• Last Update Posted Date: February 20, 2017
• Study Start Date: April 2010
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2016)

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.

• Original Primary Outcome Measures (submitted: April 7, 2010): improvement in severity of OCD symptoms as measured by the YBOCS (Yale-Brown Obsessive Compulsive Scale) [ Time Frame: 2 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)
• Official Title: Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine
• Brief Summary: In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Obsessive-Compulsive Disorder

Intervention

• Drug: Ketamine infusion
  0.5mg/kg IV over 40 minutes
  Other Name: Ketamine hydrochloride
• Other: Saline
  saline infusion

Study Arms

• Active Comparator: Group A
  0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
  Interventions:

  • Drug: Ketamine infusion
  • Other: Saline
• Active Comparator: Group B
  IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
  Interventions:

  • Drug: Ketamine infusion
  • Other: Saline

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 6, 2016): 15
• Original Estimated Enrollment (submitted: April 7, 2010): 10
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01100255
• Other Study ID Numbers: 6906R/5883
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: New York State Psychiatric Institute
• Original Responsible Party: Carolyn Rodriguez, M.D., Ph.D., Columbia-NYSPI-RFMH
• Current Study Sponsor: New York State Psychiatric Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: New York State Psychiatric Institute
• Verification Date: January 2017