BridgeMD
A study for adolescents who are depressed and thinking of suicide
EU CTIS ID: 2024-518615-19-00
What this study is testing
To assess the efficacy of a single (first) dose of 84 mg esketamine compared with psychoactive placebo (oral midazolam) in addition to comprehensive SoC in rapidly reducing the symptoms of MDD in participants 12 to <18 years of age with acute suicidal ideation or behavior
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Adolescents: 12 to <18 years
- 2. Meet DSM-5 diagnostic criteria for MDD, without psychotic features, based upon clinical assessment and MINI-KID (Sheehan 2010).
- 3. CGI-SS-R score of “Markedly suicidal” or greater (ie, ≥4) at both screening and baseline (predose) visits.
- 4. Acute psychiatric hospitalization is clinically warranted due to subject’s acute suicidality.
- 5. CDRS-R total score ≥58 (moderate to severe depression) at baseline (predose).
- 6. As part of SoC treatment, the participant must agree to: a. be hospitalized voluntarily for a recommended period of 5 days (4 nights) from Day 1, Randomization Day b. take 1 of the following prescribed SoC SSRI antidepressants, as approved and available in the participating country/territory: fluoxetine, escitalopram, or sertraline at least during the DB treatment phase.
You likely can't join if
- 1. Current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder, borderline personality disorder.
- 2. Current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis.
- 3. History of moderate or severe Substance or Alcohol Use Disorder
- 4. Participant has received prior (lifetime) treatment with (es) ketamine (other than for anesthetic purposes).
- 5. Body weight of <40 kg at screening visit.
See the full eligibility criteria
- 1. Adolescents: 12 to <18 years
- 2. Meet DSM-5 diagnostic criteria for MDD, without psychotic features, based upon clinical assessment and MINI-KID (Sheehan 2010).
- 3. CGI-SS-R score of “Markedly suicidal” or greater (ie, ≥4) at both screening and baseline (predose) visits.
- 4. Acute psychiatric hospitalization is clinically warranted due to subject’s acute suicidality.
- 5. CDRS-R total score ≥58 (moderate to severe depression) at baseline (predose).
- 6. As part of SoC treatment, the participant must agree to: a. be hospitalized voluntarily for a recommended period of 5 days (4 nights) from Day 1, Randomization Day b. take 1 of the following prescribed SoC SSRI antidepressants, as approved and available in the participating country/territory: fluoxetine, escitalopram, or sertraline at least during the DB treatment phase.
- 7. Medically stable
- 1. Current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder, borderline personality disorder.
- 2. Current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis.
- 3. History of moderate or severe Substance or Alcohol Use Disorder
- 4. Participant has received prior (lifetime) treatment with (es) ketamine (other than for anesthetic purposes).
- 5. Body weight of <40 kg at screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- China
- United States
- Taiwan
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 - 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; China; United States; Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.