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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

This trial is testing a nasal spray of ketamine to help people with severe depression or bipolar disorder who are at risk of suicide. This treatment is being tested because current options are not effective enough for these patients. Ketamine is expected to work quickly to improve mood and reduce suicidal thoughts. Originally used as an anesthetic, ketamine has shown rapid antidepressant effects and is being explored for its potential to quickly reduce suicidal thoughts in these patients.

Eligible Conditions
  • Depression
  • Adolescent Suicidality
  • Alcoholism
  • Suicidal Thoughts

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI)
Secondary study objectives
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
946 Previous Clinical Trials
344,416 Total Patients Enrolled
18 Trials studying Depression
3,417 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
~4 spots leftby Nov 2025
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