Esketamine for Major Depressive Disorder in Adolescents
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Recruiting
Phase 3
Interventional Study
Depressive Disorder, Major
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 258 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
Who this trial is looking for
This trial is looking for adolescents with major depressive disorder who have thoughts of harming themselves. Participants will receive treatment with a drug called JNJ-54135419 and will be monitored for changes in their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with major depressive disorder.
- I have a serious level of suicidal thoughts.
- I have a specific depression score at the start of the trial.
- My doctor thinks I need immediate psychiatric care.
- I am medically stable according to my doctor.
You may not be able to join if
- I have a diagnosis of bipolar disorder or similar conditions.
- I currently meet the criteria for borderline personality disorder.
- I have had a psychotic disorder.
- I have a history of seizures.
- I am allergic to certain medications used in this trial.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent part…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KI…
Contacts