NCT04861051

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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
26mo left

Started Jul 2021

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 Progress69%
Jul 2021Aug 2028

First Submitted

Initial submission to the registry

April 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 26, 2021

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

April 22, 2021

Last Update Submit

April 21, 2026

Conditions

Epilepsy

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

OTHER

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

Drug: Ketamine

Interventions

KetamineDRUG

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

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 Stanford Epilepsy Monitoring Unit
  • Age \>18 years old.

You may not qualify if:

  • Lifetime psychotic or bipolar disorder
  • Inability to speak, read or understand English
  • Pregnant or nursing females
  • Prior adverse ketamine response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

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 of Bioengineering and of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 27, 2021

Study Start

July 26, 2021

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(1)