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Summary

for people ages 12–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.

Official Title

A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide

Details

This study will enroll participants with major depressive disorder (MDD) presenting with suicidal ideation who are assessed to be at imminent risk for suicide. The study will be conducted in 4 phases: a screening evaluation performed within 48 hours prior to Day 1 intranasal dose; a 25-day double-blind treatment phase (Days 1-25); an 8‑week initial post-treatment phase (Days 25-81); and a subsequent phase to complete a full 6‑month post-treatment follow-up (Days 81-200). Efficacy, safety, pharmacokinetic, biomarker, and pharmacogenomic evaluations will be performed in the study at defined schedule. The duration of the participant's participation will be approximately 29 weeks.

Keywords

Depressive Disorder, Major Pharmaceutical Solutions Midazolam

Eligibility

You can join if…

Open to people ages 12–17

  • Participants must meet diagnostic and statistical manual of mental disorders (5th edition) {DSM-5} diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the mini international neuropsychiatric interview for children and adolescents (MINI KID)
  • Participant must have a children's depression rating scale-revised (CDRS-R) total score of equal or more than (>=) 58 predose on Day 1
  • As part of standard of care treatment, participant must agree to be hospitalized voluntarily for a recommended period of 5 days after randomization (may be shorter or longer if clinically warranted in the investigator's opinion)
  • As part of the newly initiated or optimized standard of care treatment, participant must agree to take one of the prescribed non-investigational antidepressant medications (fluoxetine, escitalopram, sertraline) at least during the double-blind treatment phase (Day 25)
  • As part of standard of care treatment, participant must agree to participate in a specific psychological intervention (individual cognitive behavioral therapy [CBT],interpersonal therapy, family therapy or psychodynamic psychotherapy) at least through the initial 8-week post-treatment follow-up period (Day 81)

You CAN'T join if...

  • Participants has a current DSM-5 diagnosis of bipolar (or related disorders),intellectual disability, autism spectrum disorder, conduct disorder, anorexia nervosa,oppositional defiant disorder, or obsessive compulsive disorder
  • Participants currently meets DSM-5 criteria for borderline personality disorder.Participants not meeting full DSM-5 criteria for borderline personality disorder but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviors should also be excluded
  • Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis
  • Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder (except for nicotine or caffeine) within the 6 months before screening. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary
  • Participant has a history of seizure disorder

Locations

  • University of Texas Southwestern Medical Center not yet accepting patients
    Dallas, Texas, 75390-9063, United States
  • University of Iowa, Carver College of Medicine not yet accepting patients
    Iowa City, Iowa, 52242, United States
  • Lake Charles Clinical Trials not yet accepting patients
    Lake Charles, Louisiana, 70629, United States
  • SIU School of Medicine not yet accepting patients
    Springfield, Illinois, 62703, United States
  • Rush University Medical Center not yet accepting patients
    Chicago, Illinois, 60612, United States
  • University of Cincinnati Hospital not yet accepting patients
    Cincinnati, Ohio, 45219, United States
  • Atlanta Center for Medical Research not yet accepting patients
    Atlanta, Georgia, 30331, United States
  • Ohio State University not yet accepting patients
    Columbus, Ohio, 43210, United States
  • University Hospital of Cleveland not yet accepting patients
    Cleveland, Ohio, 44106, United States
  • Wake Forest Baptist Medical Center not yet accepting patients
    Winston-Salem, North Carolina, 27157, United States
  • State University of New York at Buffalo not yet accepting patients
    Buffalo, New York, 14215, United States
  • University North Carolina at Chapel Hill not yet accepting patients
    Chapel Hill, North Carolina, 27599, United States
  • Sheppard Pratt Health System not yet accepting patients
    Baltimore, Maryland, 21204, United States
  • Johns Hopkins Hospital, Child and Adolescent Psychiatry not yet accepting patients
    Baltimore, Maryland, 21224, United States
  • Columbia University Medical Center not yet accepting patients
    New York, New York, 10032, United States
  • Institute of Living/ Hartford Hospital not yet accepting patients
    Hartford, Connecticut, 06106, United States
  • Yale University not yet accepting patients
    New Haven, Connecticut, 06437, United States
  • Hospital Infantil Pequeno Príncipe - Associação Hospitalar de Proteção à Infância Dr. Raul Car not yet accepting patients
    Curitiba, 80250-060, Brazil
  • Bioserv SMO - HSVP ( Hospital São Vicente de Paulo) not yet accepting patients
    Passo Fundo, 99010-080, Brazil
  • Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS not yet accepting patients
    Porto Alegre, 90035-003, Brazil
  • Hospital Estadual Mario covas not yet accepting patients
    Santo André, 09190-615, Brazil
  • Hopital Erasme not yet accepting patients
    Brussels, 1070, Belgium
  • Hôpital Universitaire Pitié-Salpêtrière not yet accepting patients
    Paris, 75013, France
  • Hôpital Robert Debré not yet accepting patients
    Paris, 75019, France
  • CHU Saint-etienne not yet accepting patients
    Saint-Priest-En-Jarez, 42270, France
  • Hosp. Univ. Fundacion Alcorcon not yet accepting patients
    Alcorcón, 28922, Spain
  • Hosp. Clinic I Provincial de Barcelona not yet accepting patients
    Barcelona, 08036, Spain
  • Hosp. Gral. Univ. Gregorio Maranon not yet accepting patients
    Madrid, 28007, Spain
  • Clinica Univ. de Navarra not yet accepting patients
    Pamplona, 31008, Spain
  • Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ not yet accepting patients
    Krakow, 31-501, Poland
  • Wojewodzki Szpital Dla Nerwowo i Psychicznie Chorych im. dra Jozefa Bednarza, oddzial IX a withdrawn
    Swiecie, 86-100, Poland
  • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego, Oddział Psychiatryczny Dzieci i Młodzież not yet accepting patients
    Wroclaw, 51-149, Poland
  • Vadaskert Gyermek- és Ifjúságpszichiátriai Kórház és Szakambulancia not yet accepting patients
    Budapest, Hungary
  • Szegedi Tudomanyegyetem not yet accepting patients
    Szeged, Hungary
  • Mental Health Center - Rousse not yet accepting patients
    Rousse, Bulgaria
  • Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD not yet accepting patients
    Varna, Bulgaria

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT03185819
Phase
Phase 2
Study Type
Interventional
Last Updated
August 1, 2017
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