Understanding Ketamine's Dissociative Effects (KD Study)

Phase 1

Recruiting

• Conditions: Epilepsy
• Interventions: Drug: Ketamine

• Registration Number: NCT04861051
• 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 dissociation in epilepsy patients with stereoEEG.

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Study Start: 2021-07-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20
• Primary Completion: 2024-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	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 School of Medicine; 🇺🇸 Palo Alto, California, United States