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NCT04861051 Clinical Trial

Understanding Ketamine's Dissociative Effects (KD Study)

Epilepsy Clinical Trial

Official title:
Understanding Ketamine's Dissociative Effects in Epilepsy (KD Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04861051
Other study ID # 60085
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 26, 2021
Est. completion date August 1, 2025

Study information
Verified date July 2023
Source Stanford University
Contact Dariana Gil-Hernandez, BA
Phone 650-724-8902
Email dariana@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during dissociation in epilepsy patients with stereoEEG.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date August 1, 2025
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient in Stanford Epilepsy Monitoring Unit - Age >18 years old. Exclusion Criteria: - Lifetime psychotic or bipolar disorder - Inability to speak, read or understand English - Pregnant or nursing females - Prior adverse ketamine response

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ketamine
Study participants will receive 0.5mg/kg of ketamine - one single infusion

Locations
Country Name City State
United States Stanford University School of Medicine Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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