A study for adolescents who are depressed and thinking of suicide

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

22 Apr 2026 → ongoing

Decision date (initial)

2025-11-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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

Conditions and MedDRA coding

Major Depressive Disorder

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-000022-PIP41-10

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Adolescents: 12 to <18 years
2. 2. Meet DSM-5 diagnostic criteria for MDD, without psychotic features, based upon clinical assessment and MINI-KID (Sheehan 2010).
3. 3. CGI-SS-R score of “Markedly suicidal” or greater (ie, ≥4) at both screening and baseline (predose) visits.
4. 4. Acute psychiatric hospitalization is clinically warranted due to subject’s acute suicidality.
5. 5. CDRS-R total score ≥58 (moderate to severe depression) at baseline (predose).
6. 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. 7. Medically stable

Exclusion criteria 5

1. 1. Current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder, borderline personality disorder.
2. 2. Current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis.
3. 3. History of moderate or severe Substance or Alcohol Use Disorder
4. 4. Participant has received prior (lifetime) treatment with (es) ketamine (other than for anesthetic purposes).
5. 5. Body weight of <40 kg at screening visit.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline (Day 1, predose) at 24 hours post first dose in depressive symptoms, as measured by the CDRS-R total score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 7

Locations

4 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 69 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications