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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05962424
Other study ID # 70198
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 5, 2023
Est. completion date September 1, 2026

Study information

Verified date November 2023
Source Stanford University
Contact Kishandra Patron, BS
Phone 6503025923
Email kpatron@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 antidepressant therapy and the side effect of dissociation. This research is designed to probe altered cognitive states associated with dissociation, depression, and other neuropsychiatric conditions.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient in clinical neuro inpatient units at Stanford Medical Center - Age >18 years old - Female participants are expected to use an effective method of birth control throughout the study which includes: hormonal methods (birth control pills, patches, injections, vaginal ring or implants), barrier methods (condom or diaphragm) used with spermicide, intrauterine device (IUD), or abstinence (no sex) Exclusion Criteria: - Lifetime psychotic disorder - Pregnant or nursing females - Prior adverse ketamine response - Use of ketamine in past 7 days

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine Hydrochloride
Ketamine is an FDA-approved dissociative anesthetic.

Locations

Country Name City State
United States Stanford University 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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