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
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy

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