← Back to Search

NMDA Receptor Antagonist

Ketamine + Midazolam for Depression (UNIKET Trial)

Phase 2
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects, 18-65 years of age and body weight less than or equal to 120 kg on baseline visit
For MDD: Subjects must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current unipolar depression [major depressive disorder (MDD) or persistent depressive disorder (PDD) in a current major depressive episode (MDE)] based on MINI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at 14 days
Awards & highlights

UNIKET Trial Summary

This trial is looking at how different drugs affect people with depression who also have problems with irritability.

Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) who can undergo MRI scans and are willing to receive ketamine or midazolam infusions. Healthy controls without psychiatric conditions can also participate. All must understand English, not be on certain medications, agree to use contraception, and not have a high risk of substance abuse or suicidal behavior.Check my eligibility
What is being tested?
The study examines brain function related to irritability in people with MDD using MRIs before and after administering either ketamine or midazolam. It aims to identify how these treatments affect the neurocircuitry associated with irritability compared to healthy individuals.See study design
What are the potential side effects?
Ketamine may cause disorientation, dizziness, nausea, increased blood pressure, mood changes, and hallucinations. Midazolam might lead to sleepiness, memory issues, slow breathing rate especially if combined with other sedatives or alcohol.

UNIKET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old and weigh 120 kg or less.
Select...
I have been diagnosed with major depression or persistent depressive disorder.
Select...
I am a man who will use birth control and not donate sperm while on the trial.
Select...
I agree to have brain scans and receive drug infusions for my depression study.

UNIKET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Resting state functional connectivity.
Striatal response to frustrative nonreward (FNR).
Treatment-related change in striatal response to FNR.
+1 more
Secondary outcome measures
Acute behavioral changes measured by Brief Psychiatric Rating Scale (BPRS)
Change in behavior (including anger attacks) measured by AAQ
Change in patient reported side effects measured by PRISE Adverse Event scores
+5 more
Other outcome measures
Body Weight Changes

UNIKET Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Healthy ControlsActive Control1 Intervention
Healthy controls will undergo clinician assessments and fMRI to compare to MDD group.
Group II: MDD - KetamineActive Control1 Intervention
Participants with MDD who have completed all baseline assessments including pre-treatment fMRI scan randomly allocated to receive four ketamine infusions.
Group III: MDD - MidazolamPlacebo Group1 Intervention
Participants with MDD who have completed all baseline assessments including pre-treatment fMRI scan randomly allocated to receive four midazolam infusions.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,619 Total Patients Enrolled
45 Trials studying Depression
19,217 Patients Enrolled for Depression

Media Library

Ketamine Hydrochloride (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05046184 — Phase 2
Depression Research Study Groups: MDD - Midazolam, Healthy Controls, MDD - Ketamine
Depression Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT05046184 — Phase 2
Ketamine Hydrochloride (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05046184 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT05046184 — Phase 2

Frequently Asked Questions

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

Is it possible for me to sign up for participation in this trial?

"This clinical trial is open to 180 participants between 18 and 65 years old who have been clinically assessed with melancholia."

Answered by AI

What objectives are being sought through this research?

"The focal objective of this clinical trial, which will be monitored across Baseline and 14 days, is to ascertain the resting state functional connectivity. Supplementary objectives include gauging changes in symptoms such as anxious arousal via Mood and Anxiety Symptoms Questionnaire (MASQ), patient reported side effects by Patient Rated Inventory of Side Effects (PRISE) Adverse Event visit checklist, and irritability levels after two weeks of twice-weekly infusions of ketamine versus midazolam with Concise Associated Symptom Tracking scale (CAST-IRR). For MASQ scores can range from 1-5 where higher numbers signify a poorer result; PRISE"

Answered by AI

What therapeutic aims are typically addressed with MDD-Ketamine?

"MDD - Ketamine is a common medication for seizure management and epileptic treatment. This medicine has also been proven to be beneficial in managing amnesia, certain therapeutic procedures, and additional forms of seizures."

Answered by AI

Has the FDA granted approval for MDD - Ketamine therapies?

"With some evidence of safety, but no data demonstrating its efficacy yet, we have assigned a score of 2 for MDD-Ketamine's safety rating."

Answered by AI

What is the uppermost capacity of participants in this research?

"Affirmative. The clinicaltrials.gov database shows that this trial is currently recruiting with the initial post date of 5/5/2022 and an update on 5/19/2022. 180 patients are needed for this medical study at 1 site."

Answered by AI

Is there an age limit for individuals to be included in this trial?

"Entrants to this clinical trial must be of legal age and no older than 65 years old."

Answered by AI

Is there still an opportunity for people to participate in this research?

"Affirmative, the information on clinicaltrials.gov reveals that this research is actively seeking enrolment from volunteers. This trial was initially made available to participants on May 5th 2022 and most recently updated on May 19th of the same year. A total of 180 participants are needed for this study, which will take place at one site."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Texas
What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Can i get help with transportation?
PatientReceived no prior treatments

Why did patients apply to this trial?

Suffering from severe depression for decades. I have tried many medications, types of therapy, being active, vitamins, etc for treatment and I still suffer and I want to see if something else might work. I also would like to be apart of something that could potentially help others. I have also read about the researching being done with ketamine as a treatment for depression and when I saw this trial I knew I had to apply.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. UT Southwestern Medical Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Elucidating the Neurocircuitry of Irritability With High-Field Neuroimaging to Identify Novel Therapeutic Targets
Manish Jha 2022. "Elucidating the Neurocircuitry of Irritability With High-Field Neuroimaging to Identify Novel Therapeutic Targets". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05046184.
All > Mdd
~97 spots leftby Aug 2026
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