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NMDA receptor antagonist

Low-Dose Ketamine Effects in Healthy Volunteers

Phase 1 & 2
Waitlist Available
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-55
Capable of understanding the study procedures and able to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up compare within day changes in bprs in response to infusion of ketamine, as measured by the clinical scale. calculated by post-pre changes, with higher values indicating higher response. two scans will be completed, 7 days apart
Awards & highlights

Study Summary

This trial will determine the lowest dose of ketamine that still produces a robust phBOLD response in healthy volunteers. The study will be double-blind, meaning that neither the subjects nor the researchers will know which dose each subject is receiving.

Who is the study for?
This trial is for healthy individuals aged 18-55 who can consent to the study and agree to use reliable birth control. Excluded are those with metal implants, a family history of schizophrenia, positive drug tests, suicidal ideation, psychotropic medication use, past psychiatric disorders (except nicotine), recreational ketamine/PCP use or adverse reaction to ketamine, pregnancy/breastfeeding women, history of violence or significant medical/neurological illnesses.Check my eligibility
What is being tested?
The trial is testing how different doses of Ketamine Hydrochloride affect brain activity in healthy volunteers using pharmacoBOLD imaging. Each participant will undergo two sessions with the same dose based on their weight but not exceeding 0.08 mg/kg. The exact dose won't be disclosed to participants; however, it will be known by the physician overseeing the study.See study design
What are the potential side effects?
Ketamine may cause side effects such as feelings of disconnection from reality or one's body (dissociation), changes in perception (like visual disturbances), nausea, dizziness, increased heart rate and blood pressure during infusion which typically resolve shortly after.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
Select...
I understand the study and can give my consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compare within day changes in bprs in response to infusion of ketamine, as measured by the clinical scale. calculated by post-pre changes, with higher values indicating higher response. two scans will be completed, 7 days apart
This trial's timeline: 3 weeks for screening, Varies for treatment, and compare within day changes in bprs in response to infusion of ketamine, as measured by the clinical scale. calculated by post-pre changes, with higher values indicating higher response. two scans will be completed, 7 days apart for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brief Psychiatric Rating Scale (BPRS)
PhBOLD

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

Trial Design

1Treatment groups
Experimental Treatment
Group I: KetamineExperimental Treatment1 Intervention
ketamine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~910

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,872 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,689,072 Total Patients Enrolled

Media Library

Ketamine Hydrochloride (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04589208 — Phase 1 & 2
Healthy Subjects Research Study Groups: Ketamine
Healthy Subjects Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT04589208 — Phase 1 & 2
Ketamine Hydrochloride (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04589208 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility requirements for participation in this research?

"This medical experiment is looking for 50 individuals aged 18 to 55 who are currently suffering from a psychotic disorder. Additionally, all participants must fall within the aforementioned age bracket of 18-55 years old."

Answered by AI

Is recruitment still open for this clinical investigation?

"Indeed, clinicaltrials.gov has evidence that this research study is in the midst of recruiting patients. It was shared on January 1st 2021 and adjusted most recently on July 25th 2022 with a purpose to collect data from 50 subjects at one trial site."

Answered by AI

Are octogenarians considered viable candidates for the clinical trial?

"The parameters of this experiment require that all eligible candidates are between 18 to 55 years old. In ancillary trials, there are a total of 130 under-18 participants and 551 over 65 enrollees."

Answered by AI

What is the aggregate number of participants in this trial?

"Affirmative. Information hosted on clinicaltrials.gov verifies that this scientific research, which was initially posted January 1st 2021, is currently recruiting participants. Around 50 candidates must be enrolled from a single site."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
New York
How old are they?
18 - 65
What site did they apply to?
New York State Psychiatric
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I am happy to help.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)
Joshua Kantrowitz 2021. "Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04589208.
~5 spots leftby Dec 2024
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