Back to resultsUnderstanding Ketamine's Dissociative Effects (KD Study)
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
About this trial
This is an interventional basic science trial for Epilepsy
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
Sites / Locations
- Stanford University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ketamine
Arm Description
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Outcomes
Primary Outcome Measures
Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04861051
Brief Title
Understanding Ketamine's Dissociative Effects (KD Study)
Official Title
Understanding Ketamine's Dissociative Effects in Epilepsy (KD Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Other
Arm Description
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Primary Outcome Measure Information:
Title
Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)
Description
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.
Time Frame
up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dariana Gil-Hernandez, BA
Phone
650-724-8902
Email
dariana@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Deisseroth, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Deisseroth, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Understanding Ketamine's Dissociative Effects (KD Study)
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