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Understanding Ketamine's Dissociative Effects (KD Study)

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04861051
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
48.2
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to understand how ketamine brings about dissociative symptoms.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Understanding Ketamine's Dissociative Effects in Epilepsy (KD Study)
Actual Study Start Date :
Jul 26, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Ketamine

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

Drug: Ketamine
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Other Names:
  • Ketalar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Palo Alto California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karl Deisseroth, Professor of Bioengineering and of Psychiatry and Behavioral Sciences, Stanford University
    ClinicalTrials.gov Identifier:
    NCT04861051
    Other Study ID Numbers:
    • 60085
    First Posted:
    Apr 27, 2021
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    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
    Additional relevant MeSH terms:
    Epilepsy
    Ketamine

    Study Results

    No Results Posted as of Sep 23, 2021