HNC: Human Neural Circuits Electrophysiology During Cognition

Phase 1

Recruiting

• Conditions: Psychiatric Disorder
• Interventions: Drug: Ketamine Hydrochloride

• Registration Number: NCT05962424
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Study Start: 2023-10-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-28
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine Hydrochloride	Study participants will receive 0.5mg/kg of ketamine - one single infusion

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States