NCT05962424

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
52mo left

Started Oct 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Oct 2023Sep 2030

First Submitted

Initial submission to the registry

July 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

6.9 years

First QC Date

July 18, 2023

Last Update Submit

April 21, 2026

Conditions

Psychiatric Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 1 week

Study Arms (1)

Ketamine

EXPERIMENTAL

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

Drug: Ketamine Hydrochloride

Interventions

Ketamine HydrochlorideDRUG

Ketamine is an FDA-approved dissociative anesthetic.

Also known as: Ketalar
Ketamine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Lifetime psychotic disorder
  • Pregnant or nursing females
  • Prior adverse ketamine response
  • Use of ketamine in past 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94306, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Karl Deisseroth, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arjay Cordero

CONTACT

650-580-9000arjayc@stanford.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 27, 2023

Study Start

October 5, 2023

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)