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HNC: Human Neural Circuits Electrophysiology During Cognition

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05962424
Collaborator
(none)
120
Enrollment
1
Arm
36
Anticipated Duration (Months)

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
  • Drug: Ketamine Hydrochloride
 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 antidepressant therapy and the side effect of dissociation. This research is designed to probe altered cognitive states associated with dissociation, depression, and other neuropsychiatric conditions.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
HNC: Human Neural Circuits Electrophysiology During Cognition
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketamine

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

Drug: Ketamine Hydrochloride
Ketamine is an FDA-approved dissociative anesthetic.
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 clinical neuro inpatient units at Stanford Medical Center

    • Age >18 years old

    • Female participants are expected to use an effective method of birth control throughout the study which includes: hormonal methods (birth control pills, patches, injections, vaginal ring or implants), barrier methods (condom or diaphragm) used with spermicide, intrauterine device (IUD), or abstinence (no sex)

    Exclusion Criteria:

    • Lifetime psychotic disorder

    • Pregnant or nursing females

    • Prior adverse ketamine response

    • Use of ketamine in past 7 days

    Contacts and Locations

    Locations

    No locations specified.

    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, Stanford University
    ClinicalTrials.gov Identifier:
    NCT05962424
    Other Study ID Numbers:
    • 70198
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Dissociative Disorders
    Ketamine

    Study Results

    No Results Posted as of Jul 27, 2023