Depressive Disorder, MajorPhase 2NCT03185819
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
A Phase 2 study testing Midazolam and Esketamine in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 51 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Midazolam and Esketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 51 sitesin 9 countries
- Study dates
- 5 Oct 2017to 31 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
51 sites in 9 countries.
51 sites in 9 countries
United States18 sites
Atlanta Behavioral Research, LLC
Atlanta, Georgia, 30338
Sheppard Pratt Health System
Baltimore, Maryland, 21204
State University of New York at Buffalo
Buffalo, New York, 14215
University North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati Hospital
Cincinnati, Ohio, 45219
University Hospital of Cleveland
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9063
CBH Health
Gaithersburg, Maryland, 20877
Institute of Living/ Hartford Hospital
Hartford, Connecticut, 06106
University of Iowa, Carver College of Medicine
Iowa City, Iowa, 52242
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Yale University
New Haven, Connecticut, 06520
Beacon Medical Group Clinical Research
South Bend, Indiana, 46617
Neuroscience Research Institute
Winfield, Illinois, 60190
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103
Spain8 sites
Hosp Clinic de Barcelona
Barcelona, 08036
Hosp. Sant Joan de Deu
Esplugues de Llobregat, 08950
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Hosp. Infantil Univ. Nino Jesus
Madrid, 28009
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222
Hosp. Univ. Central de Asturias
Oviedo, 33011
Clinica Univ. de Navarra
Pamplona, 31008
Corporacio Sanitari Parc Tauli
Sabadell, 08208
Italy7 sites
Azienda Ospedaliera G. Brotzu
Cagliari, 09134
OSP RIUNITI-DIP Donna- Bambino
Foggia, 71122
Ospedale di Merano
Merano, 39012
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, 98125
Azienda Ospedaliera Universitaria Federico II
Naples, 80138
IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, 27100
Irccs Burlo-Garofalo
Trieste, 34137
France6 sites
Hospices Civils de Lyon HCL
Bron, 69677
CHRU Lille - Hôpital Fontan 1
Lille, 59000
CHU Nantes
Nantes, 44093
Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013
Hopital Sainte Anne
Paris, 75014
Hôpital Robert Debré
Paris, 75019
Brazil4 sites
Trial Tech Tecnologia em Pesquisas com Medicamentos
Curitiba, 80240-280
Hospital Universitario Professor Edgar Santos
Salvador, 40110-060
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09715-090
Hospital São Sebastião
Turvo, 88930-000
Poland3 sites
Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ
Krakow, 31-501
Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego
Warsaw, 02 091
Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy
Warsaw, 02-957
Bulgaria2 sites
Mental Health Center - Rousse
Rousse, 7003
Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD
Varna
Hungary2 sites
Vadaskert Gyermek es Ifjusagpszichiatriai Korhaz es Szakambulancia
Budapest
Szegedi Tudomanyegyetem
Szeged
About this study
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
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.
Read the detailed description
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. If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255.
- Conditions
- Depressive Disorder, Major
- Being tested
- Intranasal Placebo, Midazolam Placebo Solution, Midazolam, Esketamine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal PlaceboDrug
Participants will receive placebo as intranasal dose to match intranasal esketamine.
Midazolam Placebo SolutionDrug
Participants will receive placebo as oral dose to match midazolam drug.
MidazolamDrug
Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.
EsketamineDrug
Participants will receive esketamine at a dose of 28 mg as intranasal solution.
EsketamineDrug
Participants will receive esketamine at a dose of 56 mg as intranasal solution.
EsketamineDrug
Participants will receive esketamine at a dose of 84 mg as intranasal solution.
| Study group | Role | What they receive |
|---|---|---|
| Oral Midazolam + Intranasal Placebo | Placebo comparator | Participants will receive midazolam solution 0.125 milligram per kilogram (mg/kg) orally 2 times per week for 4 weeks and 3 intranasal doses of matched placebo to esketamine. Receives: Drug: Intranasal Placebo; Drug: Midazolam |
| Oral Placebo + Esketamine 84 mg | Experimental | Participants will receive intranasal esketamine 84 mg as 3 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks. Receives: Drug: Midazolam Placebo Solution; Drug: Esketamine |
| Oral Placebo + Esketamine 56 mg | Experimental | Participants will receive intranasal esketamine 56 mg as 2 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks. Receives: Drug: Midazolam Placebo Solution; Drug: Esketamine |
| Oral Placebo + Esketamine 28 mg | Experimental | Participants will receive intranasal esketamine 28 mg as 1 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks. Receives: Drug: Midazolam Placebo Solution; Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Day 2)
The CDRS-R is a validated 17- item, clinician-rated instrument developed to assess depressive symptomatology in children. Scores were based on interviews with both the child and their caregiver. Of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5-point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Measured: Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (i.e., Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start5 Oct 2017
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185819
- Sponsor's protocol ID
- CR108323
- Other IDs
- 2016-004422-42, ESKETINSUI2002, 2016
- Status last verified
- Apr 2025
- First submitted
- 12 Jun 2017
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Publications
Kosik-Gonzalez C, Fu DJ, Chen LN, Lane R, Bloch MH, DelBello M, Moreno C, Drevets WC, Canuso CM. Effect of Esketamine on Depressive Symptoms in Adolescents With Major Depressive Disorder at Imminent Suicide Risk: A Randomized Psychoactive-Controlled Study. J Am Acad Child Adolesc Psychiatry. 2026 Jan;65(1):42-55. doi: 10.1016/j.jaac.2025.02.015. Epub 2025 Mar 7.
PubMed 40058488
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03185819
- Acronym / sponsor ID
- CR108323
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Midazolam + Intranasal Placebo | Placebo comparator | Drug: Intranasal Placebo, Drug: MidazolamParticipants will receive midazolam solution 0.125 milligram per kilogram (mg/kg) orally 2 times per week for 4 weeks and 3 intranasal doses of matched placebo to esketamine. |
| Oral Placebo + Esketamine 84 mg | Experimental | Drug: Midazolam Placebo Solution, Drug: EsketamineParticipants will receive intranasal esketamine 84 mg as 3 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks. |
| Oral Placebo + Esketamine 56 mg | Experimental | Drug: Midazolam Placebo Solution, Drug: EsketamineParticipants will receive intranasal esketamine 56 mg as 2 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks. |
| Oral Placebo + Esketamine 28 mg | Experimental | Drug: Midazolam Placebo Solution, Drug: EsketamineParticipants will receive intranasal esketamine 28 mg as 1 intranasal doses of esketamine in each nostril (each dose contains 14 mg of esketamine) along with oral placebo 2 times per week for 4 weeks. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal PlaceboParticipants will receive placebo as intranasal dose to match intranasal esketamine. | Drug | Oral Midazolam + Intranasal Placebo |
| Midazolam Placebo SolutionParticipants will receive placebo as oral dose to match midazolam drug. | Drug | Oral Placebo + Esketamine 28 mg, Oral Placebo + Esketamine 56 mg, Oral Placebo + Esketamine 84 mg |
| MidazolamParticipants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo. | Drug | Oral Midazolam + Intranasal Placebo |
| EsketamineParticipants will receive esketamine at a dose of 28 mg as intranasal solution. | Drug | Oral Placebo + Esketamine 28 mg |
| EsketamineParticipants will receive esketamine at a dose of 56 mg as intranasal solution. | Drug | Oral Placebo + Esketamine 56 mg |
| EsketamineParticipants will receive esketamine at a dose of 84 mg as intranasal solution. | Drug | Oral Placebo + Esketamine 84 mg |
Primary outcome
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Day 2)
Time frame: Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (i.e., Day 2)
The CDRS-R is a validated 17- item, clinician-rated instrument developed to assess depressive symptomatology in children. Scores were based on interviews with both the child and their caregiver. Of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5-point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40058488Kosik-Gonzalez C, Fu DJ, Chen LN, Lane R, Bloch MH, DelBello M, Moreno C, Drevets WC, Canuso CM. Effect of Esketamine on Depressive Symptoms in Adolescents With Major Depressive Disorder at Imminent Suicide Risk: A Randomized Psychoactive-Controlled Study. J Am Acad Child Adolesc Psychiatry. 2026 Jan;65(1):42-55. doi: 10.1016/j.jaac.2025.02.015. Epub 2025 Mar 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
51 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midazolam and Esketamine in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 51 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Spain, Italy, France, Brazil and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Day 2) (time frame: Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (i.e., Day 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.