Depressive Disorder, Major study: Esketamine vs Midazolam
Official title A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
ClinicalTrials.gov ID: NCT07227454
What this study is testing
What is Esketamine (JNJ-54135419)?
An investigational intranasal spray being studied as a potential treatment to quickly reduce symptoms of major depressive disorder in adolescents with acute suicidal thoughts or behavior. It is designed to block NMDA receptors in the brain, which may lead to rapid antidepressant effects.
Also referred to as Spravato.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether esketamine works well to reduce symptoms of major depressive disorder. It also checks how safe the medicine is for teens.
- Who it's for
- You may be able to join if you are a teen with major depression and thoughts of suicide.
- What's involved
- You would get esketamine or a pretend treatment with no medicine. You would also get standard care for your depression.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based...
- Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of "Markedly" or greater (that is, greater than or equal...
- Must have a children's depression rating scale - revised (CDRS-R) total score \>= 58 at baseline (predose)
- In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality
- Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
You likely can't join if
- Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder...
- Participant currently meets DSM-5 criteria for borderline personality disorder
- Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis
- Participant has a history of seizure disorder
- Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Evanston, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- East Providence, Rhode Island, United States
- Houston, Texas, United States
- Criciúma, Brazil
- Natal, Brazil
- Salvador, Brazil
- São Bernardo do Campo, Brazil
- São Paulo, Brazil
- Budapest, Hungary
- Debrecen, Hungary
- Győr, Hungary
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Evanston, Illinois, United States; Baltimore, Maryland, United States and 37 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.