CompletedPhase 2ketamine

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Participants Assessed to be at Imminent Risk for Suicide

Sponsored by Janssen Research & Development, LLC

NCT ID
NCT03185819
Target Enrollment
147 participants
Start Date
2017-10-05
Est. Completion
2023-03-31

About This Study

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.

Conditions Studied

Depressive Disorder, Major

Interventions

  • Intranasal Placebo
  • Midazolam Placebo Solution
  • Midazolam
  • Esketamine
  • Esketamine
  • Esketamine

Eligibility

Age:9 Years - 17 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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; and 9-11 years old participants at US-sites only: fluoxetin \[preferred\], 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)

Exclusion Criteria:

* 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

Study Locations (51)

Institute of Living/ Hartford Hospital
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Atlanta Behavioral Research, LLC
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Neuroscience Research Institute
Winfield, Illinois, United States
Beacon Medical Group Clinical Research
South Bend, Indiana, United States
University of Iowa, Carver College of Medicine
Iowa City, Iowa, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
CBH Health
Gaithersburg, Maryland, United States

+41 more locations

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Participants Assessed to be at Imminent Risk for Suicide | Huxley