Understanding Ketamine's Dissociative Effects (KD Study)
Understanding Ketamine's Dissociative Effects in Epilepsy (KD Study)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Arjay Cordero
- Phone Number: 650-580-9000
- Email: arjayc@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Recruiting
- Stanford University School of Medicine
-
Contact:
- Karl Deisseroth, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Ketamine
Study participants will receive 0.5mg/kg of ketamine - one single infusion
|
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)
Time Frame: 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.
|
up to 1 week
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Karl Deisseroth, MD, PhD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 60085
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.