← Back to Search

NMDA Receptor Antagonist

Ketamine for PTSD and Depression

Phase 1
Recruiting
Led By Cristina S Albott, MD, MA
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Does not meet DSM-5 criteria for MDD, single or recurrent, moderate-severe without psychotic features
Not on medications for managing a psychiatric indication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 60 minutes pre-infusion, 24 hours post-infusion, and after infusion series up to 2 months.
Awards & highlights

Study Summary

This trial is testing whether ketamine can help reduce symptoms of PTSD and MDD in veterans who have not responded to other treatments. The study will also look at the mechanisms underlying comorbid PTSD and MDD.

Who is the study for?
This trial is for veterans aged 18-75 with PTSD and/or MDD who can read at a sixth-grade level and consent to participate. It's not for those with severe cognitive issues, psychosis-related disorders, recent substance abuse, or unstable medical conditions. Pregnant women or those unable to undergo MRI are also excluded.Check my eligibility
What is being tested?
The study tests repeated ketamine infusions against saline (placebo) in reducing symptoms of PTSD and MDD in veterans. The goal is to understand how these conditions affect brain function and structure.See study design
What are the potential side effects?
Ketamine may cause side effects like disorientation, dizziness, nausea, increased blood pressure, mood swings, blurred vision, and in rare cases dissociation or hallucinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have moderate to severe depression without psychosis.
Select...
I am not taking any medications for mental health issues.
Select...
I have been diagnosed with moderate to severe depression without psychosis.
Select...
I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 60 minutes pre-infusion, 24 hours post-infusion, and after infusion series up to 2 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 60 minutes pre-infusion, 24 hours post-infusion, and after infusion series up to 2 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Asberg Depression Rating Scale (MADRS)
Post-Traumatic Stress Disorder

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intravenous ketamine infusionsExperimental Treatment1 Intervention
Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 3 weeks.
Group II: Intravenous saline infusionsPlacebo Group1 Intervention
Six infusions of normal saline solution over 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,388 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
72 Previous Clinical Trials
14,812 Total Patients Enrolled
Cristina S Albott, MD, MAPrincipal InvestigatorMinneapolis Veterans Affairs Medical Center

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04032301 — Phase 1
Post-Traumatic Stress Disorder Research Study Groups: Intravenous saline infusions, Intravenous ketamine infusions
Post-Traumatic Stress Disorder Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT04032301 — Phase 1
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04032301 — Phase 1
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04032301 — Phase 1

Frequently Asked Questions

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

Are recruitments for this medical trial still ongoing?

"According to clinicaltrials.gov, this investigation is presently attempting to fill its research cohort; the trial was announced on September 30th 2019 and has recently been updated on January 13th 2022."

Answered by AI

Is there an age restriction on participants involved in this research?

"This research initiative is gathering individuals with ages between 18 and 75 years old."

Answered by AI

How many individuals have registered for this clinical experiment?

"Affirmative. Clinicaltrials.gov reveals that this medical trial, which was initially published on September 30th 2019, is presently in the recruitment stage. The study calls for 108 patients from a single site to partake in its research."

Answered by AI

Who is eligible to enroll in this medical study?

"This medical trial is seeking 108 participants with stress and trauma-related disorders, aged between 18 and 75. Individuals that meet these criteria may be admitted to the study."

Answered by AI

Is there an established level of security associated with Ketamine usage?

"Ketamine has been assessed as scoring a 1 on the safety scale, as this is an early phase trial and there are limited data demonstrating its efficacy or safety."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Nebraska
Minnesota
How old are they?
18 - 65
What site did they apply to?
Minneapolis Veterans Affairs Health Care System
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2
3+

Why did patients apply to this trial?

I’ve been curious about alternate treatments for PTSD and depression. My ability to engage with life has been severely impacted by PTSD (and MDD.) I was able to hold down a job my whole life (retired 5 years ago), but isolate a lot to keep safe. I would like to be able to live without so many things triggering my PTSD.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
2019. "Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04032301.
All > Mental Illness > Ptsd
~20 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top