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A study testing intranasal esketamine compared to midazolam for rapidly reducing symptoms of major depressive disorder in adolescents with suicidal thoughts or behavior

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Major Depressive Disorder in teenagers who are having thoughts of suicide or suicidal behavior. Major Depressive Disorder is a condition where a person feels very sad and hopeless for long periods of time, which can affect their daily life. The study will test a medicine called esketamine, which is given as a nasal spray into the nose. Some participants will receive esketamine while others will receive either an oral placebo or an intranasal placebo. Additionally, some participants will receive midazolam, which is given by mouth as a liquid solution. All participants will also receive standard care treatment, which includes being in the hospital and taking one of several antidepressant medicines such as fluoxetine, escitalopram, or sertraline.

The purpose of this study is to see if esketamine can quickly reduce the symptoms of depression in teenagers who are having serious thoughts about suicide. The study will compare how well esketamine works compared to the other treatments when added to the standard care that these teenagers receive.

During the study, participants will be admitted to the hospital for about five days. They will receive their assigned treatment on the first day, and doctors will measure changes in their depression symptoms over the following 24 hours and beyond. Throughout the study, participants will continue to receive the standard care treatment including their prescribed antidepressant medicine and support from healthcare professionals.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Hospital admission and baseline assessment

    On Day 1, you will be admitted to the hospital for psychiatric care due to acute suicidal thoughts or behavior.

    Before receiving any study medication, your depression symptoms will be assessed using standardized rating scales. This includes the CDRS-R (Children's Depression Rating Scale-Revised), which measures the severity of depression, and the CGI-SS-R (Clinical Global Impression-Severity of Suicidality-Revised), which assesses suicidal thoughts.

    You will be asked to stay in the hospital voluntarily for a recommended period of 5 days (4 nights) starting from Day 1.

  2. Step 2

    First dose of study medication

    On Day 1, after the baseline assessment, you will receive your first dose of study medication.

    You will be randomly assigned to receive either esketamine 84 mg nasal spray or a placebo. The placebo group will receive oral midazolam (a mild sedative) instead of esketamine, along with an inactive nasal spray. This is done to ensure the study is fair and unbiased.

    Neither you nor the study staff will know which treatment you are receiving. This is called a double-blind study.

    The nasal spray will be administered once on Day 1.

  3. Step 3

    Standard antidepressant treatment

    As part of standard care, you will begin taking one of the following antidepressant medications: fluoxetine, escitalopram, or sertraline. These belong to a class of medications called SSRIs (Selective Serotonin Reuptake Inhibitors).

    You will continue taking this antidepressant throughout the double-blind treatment phase of the study.

    The specific medication and dosage will be determined by the treating physician based on what is available and approved in your country.

  4. Step 4

    Assessment 24 hours after first dose

    On Day 2, which is 24 hours after receiving the first dose of study medication, your depression symptoms will be assessed again using the CDRS-R scale.

    This assessment is the primary measure to determine how effective the treatment is in rapidly reducing depression symptoms.

  5. Step 5

    Hospital stay and monitoring

    You will remain in the hospital for the recommended 5-day period (4 nights) for safety monitoring and comprehensive care.

    During this time, you will receive standard psychiatric care in addition to the study medication.

    Your symptoms and overall condition will be monitored regularly by medical staff.

  6. Step 6

    Continued follow-up

    After the initial hospital stay, you will continue in the double-blind treatment phase.

    You will continue taking the prescribed SSRI antidepressant during this phase.

    Additional assessments and follow-up visits will be scheduled to monitor your progress and safety.

Who can join the trial?

8 criteria

  • You must be between 12 and 17 years old
  • You must have been diagnosed with Major Depressive Disorder, which is a condition that causes persistent feelings of sadness and loss of interest, without signs of losing touch with reality
  • You must have a score showing you are markedly suicidal or higher on a specific rating scale at both the first visit and before starting treatment
  • You must need to be admitted to a psychiatric hospital, which is a specialized hospital for mental health care, because of urgent thoughts or actions related to suicide
  • You must have a score of at least 58 on a depression rating scale, which indicates moderate to severe depression
  • You must agree to stay in the hospital voluntarily for about 5 days and 4 nights starting from the first day of treatment
  • You must agree to take one of the following antidepressant medications, which are medicines used to treat depression: fluoxetine, escitalopram, or sertraline, during the treatment period
  • You must be medically stable, meaning your overall physical health is stable enough to participate safely

Who cannot join the trial?

11 criteria

  • You have a diagnosis of schizophrenia, which is a mental health condition that affects how a person thinks, feels, and behaves, or schizoaffective disorder, which is a condition that includes symptoms of both schizophrenia and mood disorders, or bipolar disorder, which is a condition that causes extreme mood swings including emotional highs and lows
  • You have a diagnosis of borderline personality disorder, which is a mental health condition that affects how you feel about yourself and others and causes problems with managing emotions and behavior
  • You have a diagnosis of antisocial personality disorder, which is a mental health condition where a person shows a pattern of disregarding or violating the rights of others
  • You have a diagnosis of intellectual disability, which means having significant limitations in intellectual functioning and adaptive behavior
  • You have a diagnosis of autism spectrum disorder, which is a developmental condition that affects communication and behavior
  • You have active psychotic symptoms, which means experiencing things like hearing voices or seeing things that are not there, or having strong beliefs that are not based in reality
  • You have a known allergy or sensitivity to esketamine, ketamine, or midazolam, which are the medications being studied, or to any of their ingredients
  • You have a medical condition where an increase in blood pressure would present a serious risk to your health
  • You have brain bleeding, abnormal connections between blood vessels in the brain, a previous stroke, which occurs when blood supply to part of the brain is blocked, or a condition causing increased pressure inside the skull
  • You are pregnant or breastfeeding
  • You have used certain medications that cannot be safely combined with the study treatment within specific time periods before starting the study
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Investigated drugs

  • Esketamine

    is a nasal spray medication used to treat symptoms of major depressive disorder. In this study, it is being tested to see if it can quickly reduce depression symptoms in teenagers who are having thoughts of suicide or suicidal behavior. The medication is given in addition to standard care treatment.

  • Midazolam

    is a medication that is normally used to help people relax or feel calm. In this study, it is being given by mouth and used as a comparison treatment to help researchers understand how well esketamine works. It is called a psychoactive placebo because it has some effects that patients can feel, which helps keep the study fair.

What is already known about the treatment

Esketamine – Esketamine is a nasal spray medication used to treat major depressive disorder, particularly in patients who experience sudden thoughts of suicide or suicidal behavior. It works by targeting specific receptors in the brain called NMDA receptors, which help regulate mood and emotional responses by affecting the communication between brain cells. This medication is given in addition to standard psychiatric care and is being studied for its ability to quickly reduce severe depression symptoms in teenagers aged 12 to 17 years old.

Investigated diseases

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness, emptiness, and loss of interest in activities that were once enjoyable. People with this disorder experience changes in sleep patterns, appetite, and energy levels. They may have difficulty concentrating, making decisions, and completing daily tasks. The condition affects how a person thinks, feels, and behaves in everyday life. Symptoms must be present for at least two weeks and represent a change from previous functioning. The disorder can occur in episodes that may recur throughout a person's life.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-518615-19-00Protocol code54135419SUI3003Estimated enrolment258 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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