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NMDA receptor antagonist

Intranasal ketamine for Depression

Phase 3
Waitlist Available
Led By Rodrigo Machado-Vieira, MD, PhD, MSc
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This trial will study the effects of ketamine on patients with depression who have or have not recently abused alcohol.

Eligible Conditions
  • Depression
  • Suicidal Thoughts
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI)
Secondary outcome measures
Alcohol Urge Questionnaire (AUQ)
Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS)
+2 more

Side effects data

From 2022 Phase 3 trial • 33 Patients • NCT03539887
71%
Cognitive side effect
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intranasal Ketamine
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intranasal ketamineExperimental Treatment1 Intervention
Intranasal ketamine
Group II: PlaceboPlacebo Group1 Intervention
non-active placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
906 Previous Clinical Trials
323,081 Total Patients Enrolled
17 Trials studying Depression
3,033 Patients Enrolled for Depression
Rodrigo Machado-Vieira, MD, PhD, MScPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
1 Previous Clinical Trials

Frequently Asked Questions

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

Are they looking for more test subjects at the moment?

"Yes, this is an ongoing trial that is looking for 50 participants at a single site, according to the latest update on clinicaltrials.gov from 7/9/2021."

Answered by AI

Who meets the standards to be included in this experiment?

"This trial is looking for 50 patients that suffer from depression and are aged between 21 and 60. The most crucial requirements for candidates are as follows: They must have an SSI score over 4 (first five items), a Columbia scale (C-SSRS) score of 4 or 5, current suicidal ideation and depressive symptoms, a DSM-IV-TR depressive episode (also MADRS greater than or equal to 12), and a Young Mania Rating Scale (YMRS) score lower than 8. In addition, the patient must have a lifetime history of suicide attempt but not be taking any medication in the last 24 hours."

Answered by AI

Are there any dangers to using ketamine as a nasal spray?

"There is evidence from earlier trials to support the safety of intranasal ketamine, which Power rates as a 3."

Answered by AI

Is this study only available to octogenarians?

"The age limit for this study is 60 years old, with a minimum age of 21."

Answered by AI

How many individuals are taking part in this clinical trial?

"Yes, this is an ongoing clinical trial that has been recruiting since May 1st, 2018. The latest update was on July 9th, 2021 and the goal is to enroll 50 participants from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Oregon
Other
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I have struggles with depression and itis taking the joy out of life for me.
PatientReceived 2+ prior treatments
I’ve tried many different methods to treat my depression. I try not to use alcohol to cope but sometimes it’s the only option just to feel okay for a little bit. But once it wears off, it’s back to the same routine. I want a life without depression and alcohol.
PatientReceived 1 prior treatment
I have major depressive disorder, bipolar disorder, generalized anxiety, panic disorder, ADHD and alcoholism among some medical issues that have landed me on disability. I am at the end of my rope. I feel helpless and hopeless and am looking for anything that may have a positive outcome. Thank you for your consideration.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

how long is trial and what all does it involve?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. The University of Texas Health Science Center at Houston: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Rodrigo Machado-Vieira, MD, PhD, MSc 2018. "Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03539887.
~5 spots leftby May 2025
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