This study wants to evaluate how well JNJ-54135419 works (how well it works) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (major depression, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive dummy treatment (placebo) (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.
Official registry: https://clinicaltrials.gov/study/NCT07227454 · Janssen Research & Development, LLC · enrollment listed as 258
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Esketamine, Midazolam, or Oral Placebo. The registry lists allocation as randomized. This study wants to evaluate how well JNJ-54135419 works (how well it works) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (major depression, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive dummy treatment (placebo) (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.
They plan to enroll about 258 people at 49 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior
Interventions: Esketamine, Midazolam, Oral Placebo, Intranasal Placebo
Primary outcome (registry wording): Change from Baseline in Depressive Symptoms Measured by Children's Depression Rating Scale - Revised (CDRS-R) Total Score at 24 Hours Post First Dose
Study Contact
Participate-In-This-Study1@its.jnj.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 37 sites outside the US on the same record
Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG).
NCT00018057 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies.
NCT02543983 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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