54135419SUI3002: A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT03097133
• Date of registration: 27/03/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: 54135419SUI3002: A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide Aspire II
• Scientific title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety 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 Adult Subjects Assessed to be at Imminent Risk for Suicide
• Date of first enrolment: June 15, 2017
• Target sample size: 230
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03097133
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Canada, Czech Republic, Czechia, France, Lithuania, Poland, Spain, Turkey, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant 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 Psychiatric Interview (MINI)

- Participants must have current suicidal ideation with intent, confirmed by a "Yes"
response to Question B3 [Think (even momentarily) about harming or of hurting or of
injuring yourself: with at least some intent or awareness that you might die as a
result; or think about suicide (ie, about killing yourself)?] AND Question B10 [Intend
to act on thoughts of killing yourself?] obtained from the MINI

- In the physician's opinion, acute psychiatric hospitalization is clinically warranted
due to participant's imminent risk of suicide

- Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of
greater than (>) 28 predose on Day 1

- As part of standard of care treatment, participant agrees to be hospitalized
voluntarily for a recommended period of 14 days after randomization (may be shorter or
longer if clinically warranted in the investigator's opinion) and take prescribed
non-investigational antidepressant therapy(ies) for at least the duration of the
double-blind treatment phase (Day 25)

Exclusion Criteria:

- Participant has a current DSM-5 diagnosis of bipolar (or related disorders),
antisocial personality disorder, or obsessive compulsive disorder

- Participant currently meets DSM-5 criteria for borderline personality disorder. Note:
Participant 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 clinical diagnosis of autism, dementia, or intellectual
disability

- Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD
with psychotic features

- Participant meets the DSM-5 severity criteria for moderate or severe substance or
alcohol use disorder, (except for nicotine or caffeine), within the 12 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 or current signs and symptoms of liver or renal
insufficiency, clinically significant cardiac (including unstable coronary artery
disease and congestive heart failure, tachyarrhythmias and recent myocardial
infarction) or vascular, pulmonary, gastrointestinal, endocrine (including
uncontrolled hyperthyroidism), neurologic (including current or past history of
seizures except uncomplicated childhood febrile seizures with no sequelae),
hematologic, rheumatologic, or metabolic (including severe dehydration/ hypovolemia)
disease

- Participant has known allergies, hypersensitivity, intolerance or contraindications to
esketamine or ketamine or its excipients



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depressive Disorder, Major

Intervention(s)

Drug: Placebo

Other: Standard of Care

Drug: Esketamine

Primary Outcome(s)

Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase [Time Frame: Baseline (Day 1, predose) and 24 hours first post dose (Day 2)]

Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase [Time Frame: Baseline (Day 1, predose) and 24 hours first post dose (Day 2)]

Secondary Outcome(s)

Treatment Satisfaction Questionnaire for Medication (TSQM-9) Domain Score at Days 15 and 25: DB Treatment Phase [Time Frame: Days 15 and 25]

Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 7 (Clinician-rated Frequency of Suicidal Thinking [FoST]) Score at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase [Time Frame: Baseline, Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25]

Change From Baseline in European Quality of Life Group, 5-Dimension, 5-Level (EQ-5D-5L) Sum Score at Days 2, 11 and 25 of the DB Treatment Phase [Time Frame: Baseline, Days 2, 11 and 25]

Change From Baseline in EQ-5D-5L Health Status Index at Days 2, 11 and 25 of the DB Treatment Phase [Time Frame: Baseline, Days 2, 11 and 25]

Number of Participants With Remission of Major Depressive Disorder (MADRS Total Score Less Than or Equal to [<=] 12): DB Treatment Phase [Time Frame: Days 1 (4 hours [h] postdose), 2, 4, 8, 11, 15, 18, 22 and 25 (predose and 4 hours postdose)]

Change From Baseline in MADRS Total Score at 4 Hours Post First Dose at Day 1 (4 Hours Post First Dose), and 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase [Time Frame: Baseline (Day 1, predose), Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25 (predose and 4 hours postdose)]

Change From Baseline in CGI-SS-R Score at 4 Hours Post First Dose at Day 1 (4 Hours Post First Dose), and 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase [Time Frame: Baseline (Day 1, predose), Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25]

Number of Participants With Treatment Emergent Vital Signs Abnormalities: DB Treatment Phase [Time Frame: Up to Day 25]

Number of Participants With Treatment Emergent Abnormal Electrocardiogram (ECG) Values at Any Time: DB Treatment Phase [Time Frame: Up to Day 25]

Change From Baseline in Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase [Time Frame: Baseline (Day 1, predose), Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25]

Change From Baseline in Quality of Life in Depression Scale (QLDS) Total Score at Days 2, 11 and 25 of the DB Treatment Phase [Time Frame: Baseline, Days 2, 11 and 25]

Number of Participants Who Achieved Resolution of Suicidality (CGI-SS-R Score of 0 or 1): DB Treatment Phase [Time Frame: Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25]

Number of Sedated Participants as Assessed by Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score at Any Time: DB Treatment Phase [Time Frame: Up to Day 25]

Change From Baseline in Beck Hopelessness Scale (BHS) Total Score at Days 8 and 25 in DB Treatment Phase [Time Frame: Baseline, Days 8 and 25]

Change From Baseline in European Quality of Life Group, Visual Analogue Scale (EQ-VAS) Score at Days 2, 11 and 25 of the DB Treatment Phase [Time Frame: Baseline, Days 2, 11 and 25]

Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 5 (My Risk) Question 3 (Participant-Reported Frequency of Suicidal Thinking) Score at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase [Time Frame: Baseline, Days 1 (4h postdose), 2, 4, 8, 11, 15, 18, 22 and 25]

Number of Participants With Abnormal Arterial Oxygen Saturation (SpO2) Levels (Less Than [<] 93%) as Assessed by Pulse Oximetry at Any Time: DB Treatment Phase [Time Frame: Up to Day 25]

Number of Participants With Abnormal Nasal Examinations at Day 25: DB Treatment Phase [Time Frame: At Day 25]

Number of Participants With an Increase in Clinician-administered Dissociative States Scale (CADSS) Total Score Over Time: DB Treatment Phase [Time Frame: Days 1, 4, 8, 11, 15, 18, 22 and 25]

Number of Participants With Treatment Emergent Abnormal Laboratory Values: DB Treatment Phase [Time Frame: Up to Day 25]

Number of Participants With Treatment Emergent Adverse Events (TEAEs): DB Treatment Phase [Time Frame: Up to Day 25]

Secondary ID(s)

CR108285

2016-003992-23

54135419SUI3002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03097133