Back to resultsHNC: Human Neural Circuits Electrophysiology During Cognition
Primary Purpose
Psychiatric Disorder
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
About this trial
This is an interventional basic science trial for Psychiatric Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
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
NCT05962424
Brief Title
HNC: Human Neural Circuits Electrophysiology During Cognition
Official Title
HNC: Human Neural Circuits Electrophysiology During Cognition
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder
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
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Other Intervention Name(s)
Ketalar
Intervention Description
Ketamine is an FDA-approved dissociative anesthetic.
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 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
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HNC: Human Neural Circuits Electrophysiology During Cognition
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