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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

Must not have

Must not be on any prohibited concomitant medication

Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at 14 days

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.

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.

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.

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 65 years old and weigh 120 kg or less.

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I have been diagnosed with major depression or persistent depressive disorder.

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I am a man who will use birth control and not donate sperm while on the trial.

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I agree to have brain scans and receive drug infusions for my depression study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medications that are not allowed in the study.

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I do not have any unstable illnesses affecting my organs or immune system.

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My sleep apnea is not fully treated.

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I am currently pregnant, nursing, or might become pregnant.

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My recent tests or heart checks did not show any major issues.

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I have a serious brain condition like Parkinson's, seizures, brain tumors, or major head injury.

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I am not allergic to ketamine or midazolam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Resting state functional connectivity.

Striatal response to frustrative nonreward (FNR).

Treatment-related change in striatal response to FNR.

+1 more

Secondary study objectives

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 study objectives

Body Weight Changes

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.

0 / 11Eligibility criteria met