Understanding Ketamine's Dissociative Effects (KD Study)

• ClinicalTrials.gov Identifier: NCT04861051
• Recruitment Status: Recruiting
• First Posted: April 27, 2021
• Last Update Posted: September 23, 2021
• Sponsor: Stanford University
• Information provided by (Responsible Party): Karl Deisseroth, Stanford University

Tracking Information

• First Submitted Date: April 22, 2021
• First Posted Date: April 27, 2021
• Last Update Posted Date: September 23, 2021
• Actual Study Start Date: July 26, 2021
• Estimated Primary Completion Date: August 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2021)

Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale) [ Time Frame: up to 1 week ]

The CADSS is an instrument for the measurement of dissociative symptoms. The CADSS comprises 23 subjective items and participant's responses are coded on a 5-point scale (0 = Not at all; 4 = Extreme). The higher the number on the CADSS, the more severe the symptoms.

• Original Primary Outcome Measures: Same as current
• 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: Understanding Ketamine's Dissociative Effects (KD Study)
• Official Title: Understanding Ketamine's Dissociative Effects in Epilepsy (KD Study)
• Brief Summary: The purpose of this study is to understand how ketamine brings about dissociative symptoms.
• Detailed Description: The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during dissociation in epilepsy patients with stereoEEG.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Epilepsy

Intervention

Drug: Ketamine

Study participants will receive 0.5mg/kg of ketamine - one single infusion

Other Name: Ketalar

Study Arms

Ketamine

Study participants will receive 0.5mg/kg of ketamine - one single infusion

Intervention: Drug: Ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 22, 2021): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2025
• Estimated Primary Completion Date: August 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient in Stanford Epilepsy Monitoring Unit
• Age >18 years old.

Exclusion Criteria:

• Lifetime psychotic or bipolar disorder
• Inability to speak, read or understand English
• Pregnant or nursing females
• Prior adverse ketamine response

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pavithra Mukunda, MS; 6504972578; pavithra.mukunda@stanford.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04861051
• Other Study ID Numbers: 60085
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

• IPD Sharing Statement: Not Provided
• Responsible Party: Karl Deisseroth, Stanford University
• Study Sponsor: Stanford University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Karl Deisseroth, MD, PhD; Stanford University

• PRS Account: Stanford University
• Verification Date: September 2021