Understanding How Ketamine Brings About Rapid Improvement in OCD (MKET)

• ClinicalTrials.gov Identifier: NCT02624596
• Recruitment Status: Active, not recruiting
• First Posted: December 8, 2015
• Last Update Posted: November 13, 2023
• Sponsor: Stanford University
• Collaborator: University of Connecticut
• Information provided by (Responsible Party): Carolyn Rodriguez, Stanford University

Tracking Information

• First Submitted Date: December 2, 2015
• First Posted Date: December 8, 2015
• Last Update Posted Date: November 13, 2023
• Study Start Date: June 2016
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2018)

improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Up to 6 months ]

Improvement in OCD severity is measured by the 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 is defined as at least a 35% reduction on the YBOCS.

• Original Primary Outcome Measures (submitted: December 7, 2015): improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Up to 6 months ]
• Current Secondary Outcome Measures (submitted: May 2, 2018): Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy [ Time Frame: up to 90 minutes ]
• Original Secondary Outcome Measures (submitted: December 7, 2015): regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy [ Time Frame: up to 90 minutes ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Understanding How Ketamine Brings About Rapid Improvement in OCD
• Official Title: NMDAR Modulation As a Therapeutic Target and Probe of Neural Dysfunction in OCD
• Brief Summary: The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.
• Detailed Description: Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to build on our discovery that a potent NMDA receptor antagonist, ketamine, has rapid (in hours) and robust therapeutic effects in OCD. The proposed projects test the acute mechanism of action of ketamine at the level of molecules, circuits, and network synchrony to determine how NMDA receptor antagonism modifies the underlying pathology of OCD to relieve repetitive thoughts and behaviors.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obsessive-Compulsive Disorder

Intervention

• Drug: Ketamine
  OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
  Other Name: Ketamine Hydrochloride
• Drug: Midazolam
  OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
  Other Name: Midazolam Hydrochloride

Study Arms

• Experimental: Ketamine
  OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
  Intervention: Drug: Ketamine
• Active Comparator: Midazolam
  OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
  Intervention: Drug: Midazolam

• Publications *: Bandeira ID, Lins-Silva DH, Cavenaghi VB, Dorea-Bandeira I, Faria-Guimaraes D, Barouh JL, Jesus-Nunes AP, Beanes G, Souza LS, Leal GC, Sanacora G, Miguel EC, Sampaio AS, Quarantini LC. Ketamine in the Treatment of Obsessive-Compulsive Disorder: A Systematic Review. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):135-145. doi: 10.1097/HRP.0000000000000330.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 7, 2015): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria for participants with OCD:

• age 18-65
• Primary diagnosis of OCD
• Sufficient severity of OCD symptoms
• ability to tolerate a treatment-free period
• capacity to provide informed consent

Inclusion criteria for healthy controls:

• ages 18-65
• capacity to provide informed consent

Exclusion criteria for participants with OCD:

• Psychiatric or medical conditions that make participation unsafe
• pregnant or nursing females
• concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
• presence of metallic device or dental braces

Exclusion criteria for healthy controls:

• any current or lifetime psychiatric diagnosis
• pregnant or nursing females
• major medical or neurological problem
• presence of metallic device or dental braces

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02624596
• Other Study ID Numbers: 34622
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Carolyn Rodriguez, Stanford University
• Original Responsible Party: Same as current
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current
• Collaborators: University of Connecticut

Investigators

• Principal Investigator: Carolyn I Rodriguez, MD, PhD; Stanford University

• PRS Account: Stanford University
• Verification Date: November 2023