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Understanding Ketamine's Dissociative Effects (KD Study)

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

Tracking Information
First Submitted Date  ICMJE April 22, 2021
First Posted Date  ICMJE April 27, 2021
Last Update Posted Date September 23, 2021
Actual Study Start Date  ICMJE July 26, 2021
Estimated Primary Completion Date August 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Understanding Ketamine's Dissociative Effects (KD Study)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: Ketamine
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Other Name: Ketalar
Study Arms  ICMJE Ketamine
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2025
Estimated Primary Completion Date August 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pavithra Mukunda, MS 6504972578 pavithra.mukunda@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04861051
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Karl Deisseroth, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karl Deisseroth, MD, PhD Stanford University
PRS Account Stanford University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP