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    Clinical Trial Results:
    A Short-term Exploratory Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents with Major Depressive Disorder Who Have an Inadequate Response to an SSRI and Psychotherapy

    Summary
    EudraCT number
    2021-000567-77
    Trial protocol
    Outside EU/EEA   ES   IT   SE  
    Global end of trial date
    08 Apr 2024

    Results information
    Results version number
    v2(current)
    This version publication date
    12 Mar 2025
    First version publication date
    24 Oct 2024
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    Secondary end points

    Trial information

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    Trial identification
    Sponsor protocol code
    42847922MDD1016
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04951609
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202 South, Raritan, New Jersey, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002746-PIP01-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Apr 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective was to assess the safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD), in short-term compared with placebo.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    United States: 22
    Worldwide total number of subjects
    30
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    30
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 31 subjects were randomised, out of which only 30 subjects were treated with either study intervention or placebo. One subject was randomised to seltorexant treatment but was not treated with the study intervention.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received a single oral dose of placebo (matching to seltorexant) tablet once daily at bedtime from Day 1 to Week 6.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single oral dose of placebo (matching to seltorexant) tablet once daily at bedtime from Day 1 to Week 6.

    Arm title
    Seltorexant 10 mg and 20 mg
    Arm description
    Subjects with body weight greater than or equal to (>=) 45 kilograms (kg) received a single oral dose of seltorexant 20 milligrams (mg) tablet once daily at bedtime and subjects with body weight >=30 kg to less than (<) 45 kg received seltorexant 10 mg tablet once daily at bedtime from Day 1 to Week 6. Subjects continued with their baseline selective serotonin reuptake inhibitor (SSRI) antidepressant (fluoxetine or escitalopram) treatment at same dose as it was prior to entering the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Seltorexant
    Investigational medicinal product code
    JNJ-42847922
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single oral dose of seltorexant 20 mg or 10 mg tablet once daily at bedtime based on the body weight from Day 1 to Week 6.

    Number of subjects in period 1
    Placebo Seltorexant 10 mg and 20 mg
    Started
    7
    23
    Completed
    6
    22
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single oral dose of placebo (matching to seltorexant) tablet once daily at bedtime from Day 1 to Week 6.

    Reporting group title
    Seltorexant 10 mg and 20 mg
    Reporting group description
    Subjects with body weight greater than or equal to (>=) 45 kilograms (kg) received a single oral dose of seltorexant 20 milligrams (mg) tablet once daily at bedtime and subjects with body weight >=30 kg to less than (<) 45 kg received seltorexant 10 mg tablet once daily at bedtime from Day 1 to Week 6. Subjects continued with their baseline selective serotonin reuptake inhibitor (SSRI) antidepressant (fluoxetine or escitalopram) treatment at same dose as it was prior to entering the study.

    Reporting group values
    Placebo Seltorexant 10 mg and 20 mg Total
    Number of subjects
    7 23 30
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    7 23 30
        Adults (18-64 years)
    0 0 0
        From 65 to 84 years
    0 0 0
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    15.9 ( 1.07 ) 15 ( 1.54 ) -
    Title for Gender
    Units: subjects
        Female
    5 17 22
        Male
    2 6 8

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single oral dose of placebo (matching to seltorexant) tablet once daily at bedtime from Day 1 to Week 6.

    Reporting group title
    Seltorexant 10 mg and 20 mg
    Reporting group description
    Subjects with body weight greater than or equal to (>=) 45 kilograms (kg) received a single oral dose of seltorexant 20 milligrams (mg) tablet once daily at bedtime and subjects with body weight >=30 kg to less than (<) 45 kg received seltorexant 10 mg tablet once daily at bedtime from Day 1 to Week 6. Subjects continued with their baseline selective serotonin reuptake inhibitor (SSRI) antidepressant (fluoxetine or escitalopram) treatment at same dose as it was prior to entering the study.

    Primary: Double-blind Phase: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

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    End point title
    Double-blind Phase: Number of Subjects with Treatment Emergent Adverse Events (TEAEs) [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent adverse events were any AE occurring at or after the initial administration of study intervention through 2 days after the last administration of study intervention. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    From start of treatment (Day 1) up to Week 6
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    7
    23
    Units: subjects
    2
    9
    No statistical analyses for this end point

    Primary: Double-blind Phase: Number of Subjects with Treatment Emergent Adverse Event of Special Interest (AESIs)

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    End point title
    Double-blind Phase: Number of Subjects with Treatment Emergent Adverse Event of Special Interest (AESIs) [2]
    End point description
    An adverse event (AE) any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent adverse events were any AE occurring at or after the initial administration of study intervention through 2 days after the last administration of study intervention. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Adverse events of special interest were cataplexy, sleep paralysis, complex, and sleep-related behaviors (parasomnias), new suicidal behavior or suicidal ideation. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    From start of treatment (Day 1) up to Week 6
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    7
    23
    Units: subjects
    0
    1
    No statistical analyses for this end point

    Primary: Double-blind Phase: Number of Symptoms as Assessed by Pediatric Adverse Event Rating Scale (PAERS)

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    End point title
    Double-blind Phase: Number of Symptoms as Assessed by Pediatric Adverse Event Rating Scale (PAERS) [3]
    End point description
    Number of symptoms as assessed by PAERS were reported. The PAERS was a patient-rated scale designed to assess adverse events occurring in pediatric subjects treated with psychotropic medication in clinical studies. Individual PAERS (patient-reported version) items rated on symptoms and severity of symptoms. PAERS scale consisted of 45 items (43 specific signs and symptoms and 2 to be specified). Individual items were rated on a scale of "0" (mild) to "4" (extreme). Safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Baseline, Day 15, Day 29, and end of double-blind phase (Week 6)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    7
    23
    Units: number of symptoms
        Baseline: Mild
    55
    177
        Baseline: Moderate
    59
    134
        Baseline: Severe
    30
    82
        Baseline: Extreme
    21
    43
        Day 15: Mild
    79
    172
        Day 15: Moderate
    33
    90
        Day 15: Severe
    13
    59
        Day 15: Extreme
    9
    26
        Day 29: Mild
    83
    154
        Day 29: Moderate
    31
    81
        Day 29: Severe
    5
    39
        Day 29: Extreme
    2
    19
        End of double-blind phase (Week 6): Mild
    74
    161
        End of double-blind phase (Week 6): Moderate
    25
    82
        End of double-blind phase (Week 6): Severe
    9
    35
        End of double-blind phase (Week 6): Extreme
    2
    16
    No statistical analyses for this end point

    Primary: Double-blind Phase: Number of Subjects with Abnormalities in Clinical Laboratory Values

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    End point title
    Double-blind Phase: Number of Subjects with Abnormalities in Clinical Laboratory Values [4]
    End point description
    Number of subjects with abnormalities in clinical laboratory values (hematology, and serum chemistry) were reported. Only those categories in which at least one subject had data are reported. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    From start of treatment (Day 1) up to end of double-blind phase (Week 6)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    6
    22
    Units: subjects
        Chemistry: Alkaline Phosphatase: high
    0
    1
        Chemistry: Cholesterol: high
    1
    3
        Chemistry: LDL Cholesterol: high
    0
    1
        Chemistry: Phosphate: high
    0
    2
    No statistical analyses for this end point

    Primary: Double-blind Phase: Number of Subjects with Abnormalities in Electrocardiogram (ECG)

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    End point title
    Double-blind Phase: Number of Subjects with Abnormalities in Electrocardiogram (ECG) [5]
    End point description
    Number of subjects with abnormalities in ECG were reported. The ECG parameters included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc). Only those categories in which at least one subject had data are reported. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "n"(number of subjects analysed) signifies number of subjects analysed at specified timepoints.
    End point type
    Primary
    End point timeframe
    Pre-dose (Day 1) and end of double-blind phase (Week 6)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    7
    23
    Units: subjects
        Pre-dose (Day 1) (n=7, 23)
    3
    0
        End of double-blind phase (Day 43): (n=6, 23)
    2
    4
    No statistical analyses for this end point

    Primary: Double-blind Phase: Number of Subjects with Abnormalities in Vital Signs

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    End point title
    Double-blind Phase: Number of Subjects with Abnormalities in Vital Signs [6]
    End point description
    Number of subjects with abnormalities in vital sign (blood pressure [systolic and diastolic blood pressure] and temperature) were reported. Only those categories in which at least one subject had data are reported. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Units for blood pressure: millimetre of mercury (mmHg).
    End point type
    Primary
    End point timeframe
    From start of treatment (Day 1) up to end of double-blind phase (Week 6)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    7
    23
    Units: subjects
        Systolic Blood Pressure: >130 mmHg
    0
    3
        Systolic Blood Pressure: <90 mmHg
    1
    2
        Diastolic Blood Pressure: >80 mmHg
    0
    2
        Diastolic Blood Pressure: <50 mmHg
    0
    0
        Temperature: >37.7 Celsius (C)
    0
    0
        Temperature: <35.5 C
    1
    0
    No statistical analyses for this end point

    Primary: Double-blind Phase: Change from Baseline in Physical Examination: Body Weight

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    End point title
    Double-blind Phase: Change from Baseline in Physical Examination: Body Weight [7]
    End point description
    Change from baseline in physical examination: waist circumference was reported. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), and end of double-blind phase (Week 6)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    6
    23
    Units: kilograms (kg)
        arithmetic mean (standard deviation)
    -1.40 ( 1.333 )
    1.15 ( 1.736 )
    No statistical analyses for this end point

    Primary: Number of Subjects with Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score

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    End point title
    Number of Subjects with Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score [8]
    End point description
    C-SSRS scale reported at least one occurrence of any suicidal behavior and ideation. Suicidal behavior: reporting any of 5 items: suicide, actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior. Suicidal ideation: consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with specific plan and intent. An event of suicidal ideation or behavior were scored on a scale of 0 (no suicidal ideation or behavior) to 10 (suicide) based on highest response at the given time point. Worsening of suicidal ideation indicated an increase in severity of suicidal ideation. Only those categories in which at least 1 subject had data are reported. Safety analysis set was analysed. Here, "n"(number of subjects analysed) signifies number of subjects analysed at specified categories.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1[D1]), Day 8, Day 15, Day 29, and end of double-blind phase (Week 6)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    7
    23
    Units: subjects
        D1: No suicidal ideation or behavior: n=7, 23
    7
    18
        D1: Wish to be dead: n=7, 23
    0
    1
        D1:Non-specific active suicidal thoughts:n=7, 23
    0
    3
        D1:Suicidal ideation without plan & intent: n=7,23
    0
    1
        D8:No suicidal ideation or behavior(n=7, 23)
    7
    21
        D8: Non-specific active suicidal thoughts(n=7, 23)
    0
    2
        D15: No suicidal ideation or behavior(n=7, 23)
    7
    20
        D15:Non-specific active suicidal thoughts:n=7, 23
    0
    2
        D15: Suicidal ideation intent without plan:n=7,23
    0
    1
        D29:No suicidal ideation or behavior (n=6, 23)
    6
    18
        D29: Wish to be dead (n=6, 23)
    0
    2
        D29:Non-specific active suicidal thoughts:n=6, 23
    0
    2
        D29:Suicidal ideation without plan & intent:n=6,23
    0
    1
        D43:No suicidal ideation or behavior(n=6, 22)
    6
    18
        D43: Wish to be dead (n=6, 22)
    0
    2
        D43:Non-specific active suicidal thoughts (n=6,22)
    0
    2
        D43:Non-suicidal self-injurious behavior(n=6, 22)
    0
    1
    No statistical analyses for this end point

    Primary: Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)

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    End point title
    Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20) [9]
    End point description
    PWC-20 was a reliable, sensitive instrument having 20-items used to assess potential withdrawal symptoms following cessation of treatment. Items were loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, stiffness, weakness, increased acuity sound smell touch (IASST), paresthesia, difficulty concentrating-, remember, derealization. Each item score ranged from 0 (not present) to 3 (severe). Total score ranges from 0-60, where higher score indicates more severe symptoms. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analysed) signifies number of subjects analysed at specified timepoints.
    End point type
    Primary
    End point timeframe
    End of double-blind phase (Week 6), Follow-up 1 (Day 45), Follow-up 2 (Day 54)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    6
    23
    Units: Units on a scale
    arithmetic mean (standard deviation)
        End of double-blind phase (Week 6) (n=6, 23)
    2.7 ( 3.78 )
    6.9 ( 6.43 )
        Follow-up 1 (Day 45) (5, 22)
    4.2 ( 3.90 )
    4.1 ( 6.57 )
        Follow-up 2 (Day 54) (6, 23)
    5.7 ( 6.65 )
    5.6 ( 5.29 )
    No statistical analyses for this end point

    Primary: Double-blind Phase: Menstrual Cycle Tracking: Duration of Menses and Length of Menstrual Cycle

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    End point title
    Double-blind Phase: Menstrual Cycle Tracking: Duration of Menses and Length of Menstrual Cycle [10]
    End point description
    Menstrual cycles were tracked during the study in female adolescents or subjects who have at least one menses' using a subject diary and subject's verbal report. Menstrual cycle duration was measured by the number of days subjects noted menstruating in their diary entry. Menstrual cycle length was assessed as the number of days between menstrual cycles (i.e., days between the start of a menstrual period and the start of the next consecutive menstrual period) from baseline to end of double-blind phase (Week 6). Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analysed) signifies number of subjects analysed at specified categories.
    End point type
    Primary
    End point timeframe
    From baseline (Day 1) up to end of double-blind phase (Week 6)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    3
    15
    Units: days
    arithmetic mean (standard deviation)
        Duration of menses (n=3, 13)
    6.0 ( 1.00 )
    6.8 ( 3.06 )
        Length of cycle (n=2, 15)
    62.0 ( 2.83 )
    45.9 ( 19.12 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Children’s Depression Rating Scale (CDRS) Total Score

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    End point title
    Change from Baseline in the Children’s Depression Rating Scale (CDRS) Total Score
    End point description
    Change from baseline in the CDRS total score were reported. The CDRS-R was a validated 17-item, clinician-rated instrument that measured the severity of a subject's depressive symptoms. The CDRS-R total score was the sum of the responses to 17 questions, ranged from 17 to 113. Each scale item was scored from 1 to 5 or 1 to 7. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). Higher scores represent a more severe condition. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and end of double-blind phase (Week 6)
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    6
    22
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -22.0 ( 9.86 )
    -21.3 ( 12.45 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score

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    End point title
    Change from Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score
    End point description
    Change from baseline in MADRS score were reported. The MADRS scale score was a 10-item clinician-administered scale designed to measure depression severity and to detect changes due to antidepressant treatment using the 10 items followed: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, & suicidal thoughts. Each item scored from 0 (no symptoms or normal) to 6 (symptoms of maximum severity), & the sum of scores of individual question items at a given time point ranged from 0 to 60. Higher scores indicated more severe condition. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and end of double-blind phase (Week 6)
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    6
    22
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -17.2 ( 10.42 )
    -14.6 ( 9.22 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impression- severity (CGI-S) Score Over Time

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    End point title
    Change from Baseline in Clinical Global Impression- severity (CGI-S) Score Over Time
    End point description
    Change from baseline in the CGI-S score were reported. The CGI-S provided an overall clinician-determined summary measure of the severity of the subject's illness. The CGI scale is an investigator-rated evaluation that assesses the severity of a subject's illness on a 7-point scale, ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Considering total clinical experience with the depression population, a subject was assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill subjects. Higher scores indicated more severe condition. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here, "n"(number analysed) signifies number of subjects analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 15, Day 29, end of double-blind phase (Week 6)
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    7
    23
    Units: units on a scale
    arithmetic mean (standard deviation)
        Day 15 (n=7, 23)
    -1.7 ( 1.11 )
    -0.7 ( 0.75 )
        Day 29 (n=6,23)
    -2.0 ( 1.26 )
    -1.2 ( 1.00 )
        Week 6 (n=6, 22)
    -2.0 ( 1.26 )
    -1.6 ( 1.14 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Subjective Sleep Assessment (Patient Reported Outcome Measurement Information System-Pediatric-Sleep Disturbance [PROMIS-Pediatric-SD]

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    End point title
    Change from Baseline in Subjective Sleep Assessment (Patient Reported Outcome Measurement Information System-Pediatric-Sleep Disturbance [PROMIS-Pediatric-SD]
    End point description
    The PROMIS-Pediatric-SD was a static 8 item questionnaire used to assess self-reported perceptions of sleep quality. Each item has 5 responses scored on a 5 level Likert-type scale. The 8-item short form were used, in which responses were scored 1 to 5 for each item. For the 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Lower scores indicate less sleep disturbance The “direction” of the responses was not the same for all questions, i.e., sometimes a response of “always” indicated more sleep disturbance and sometimes a response of “always” indicated less sleep disturbance. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and end of double-blind phase (Week 6)
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    6
    22
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -3.93 ( 9.074 )
    -8.41 ( 8.618 )
    No statistical analyses for this end point

    Secondary: Change from Baseline on Objective Sleep Assessment Actigraphy: Total Sleep Time

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    End point title
    Change from Baseline on Objective Sleep Assessment Actigraphy: Total Sleep Time
    End point description
    Change from baseline on objective sleep assessment actigraphy: total sleep time were reported. Objective sleep parameters were measured using actigraphy. Total sleep time was defined as the number of scored sleep epochs (an epoch equals 30 to 60 seconds), in minutes. Full analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analysed) signifies number of subjects analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    5
    17
    Units: minutes (min)
    arithmetic mean (standard deviation)
        Week 1 (N=5, 17)
    32.62 ( 48.351 )
    -25.22 ( 116.136 )
        Week 2 (n=5, 14)
    30.82 ( 76.472 )
    -20.64 ( 95.390 )
        Week 3 (n=5,12)
    11.44 ( 55.639 )
    5.61 ( 83.844 )
        Week 4 (n=5,11)
    17.98 ( 35.690 )
    10.14 ( 79.563 )
        Week 5 (n=4,12)
    -17.28 ( 30.116 )
    23.68 ( 68.934 )
        Week 6 (n=4,12)
    23.18 ( 51.956 )
    24.72 ( 38.304 )
    No statistical analyses for this end point

    Secondary: Change from Baseline on Objective Sleep Assessment Actigraphy: Number of Wake Bouts

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    End point title
    Change from Baseline on Objective Sleep Assessment Actigraphy: Number of Wake Bouts
    End point description
    Change from baseline on objective sleep assessment actigraphy: number of wake bouts were reported. Objective sleep parameters were measured using actigraphy. A wake bout was an epoch or continuous epochs (an epoch equals 30 to 60 seconds) scored as awake. Full analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analysed) signifies number of subjects analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    5
    17
    Units: number of wake bouts
    arithmetic mean (standard deviation)
        Week 1 (N=5, 17)
    3.54 ( 10.971 )
    -2.29 ( 14.181 )
        Week 2 (n=5,14)
    8.96 ( 16.954 )
    -1.69 ( 11.511 )
        Week 3 (n=5, 12)
    5.72 ( 18.522 )
    2.92 ( 8.492 )
        Week 4 (n=5, 11)
    1.54 ( 12.002 )
    2.94 ( 12.360 )
        Week 5 (n=4, 12)
    -9.18 ( 15.027 )
    1.93 ( 8.405 )
        Week 6 (n=4, 12)
    1.93 ( 4.562 )
    2.76 ( 8.464 )
    No statistical analyses for this end point

    Secondary: Change from Baseline on Objective Sleep Assessment Actigraphy: Sleep Efficiency

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    End point title
    Change from Baseline on Objective Sleep Assessment Actigraphy: Sleep Efficiency
    End point description
    Change from baseline on objective sleep assessment actigraphy: sleep efficiency was reported. Objective sleep parameters were measured using actigraphy. Sleep efficiency was scored total sleep time divided by total time in bed minus total invalid time, multiplied by 100, in percentages. Full analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analysed) signifies number of subjects analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    5
    17
    Units: percentage
    arithmetic mean (standard deviation)
        Week 1 (N=5,17)
    0.02 ( 0.045 )
    -0.01 ( 0.075 )
        Week 2 (N=5,14)
    0.00 ( 0.071 )
    0.01 ( 0.027 )
        Week 3 (N=5,12)
    0.02 ( 0.045 )
    -0.01 ( 0.051 )
        Week 4 (N=5,11)
    0.02 ( 0.045 )
    -0.01 ( 0.030 )
        Week 5 (N=4,12)
    0.03 ( 0.050 )
    0.01 ( 0.067 )
        Week 6 (N=4,12)
    0.08 ( 0.096 )
    -0.02 ( 0.039 )
    No statistical analyses for this end point

    Secondary: Change from Baseline on Objective Sleep Assessment Actigraphy: Sleep Onset Latency

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    End point title
    Change from Baseline on Objective Sleep Assessment Actigraphy: Sleep Onset Latency
    End point description
    Change from baseline on objective sleep assessment actigraphy: sleep onset latency was reported. Objective sleep parameters were measured using actigraphy. Sleep onset latency was time between the start of a given rest interval and the following sleep start time, in minutes. Full analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analysed) signifies number of subjects analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    5
    17
    Units: minutes
    arithmetic mean (standard deviation)
        Week 1 (N=5, 17)
    -8.04 ( 25.258 )
    1.44 ( 33.390 )
        Week 2 (n=5, 14)
    -14.06 ( 19.382 )
    -6.25 ( 11.835 )
        Week 3 (n=5, 12)
    -11.56 ( 26.961 )
    -7.99 ( 12.198 )
        Week 4 (n=5, 11)
    -11.44 ( 22.834 )
    -7.75 ( 13.613 )
        Week 5 (n=4, 12)
    -7.85 ( 9.035 )
    -8.10 ( 16.855 )
        Week 6 (n=4, 12)
    -21.75 ( 21.807 )
    -7.41 ( 13.201 )
    No statistical analyses for this end point

    Secondary: Change from Baseline on Objective Sleep Assessment Actigraphy: Wake After Sleep Onset

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    End point title
    Change from Baseline on Objective Sleep Assessment Actigraphy: Wake After Sleep Onset
    End point description
    Change from baseline on objective sleep assessment actigraphy: Wake after sleep onset was reported. Objective sleep parameters were measured using actigraphy. Wake after sleep onset was the number of epochs of the given sleep interval scored as wake by the actigraphy software, in minutes. Full analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analysed) signifies number of subjects analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    5
    17
    Units: minutes
    arithmetic mean (standard deviation)
        Week 1 (N=5, 17)
    10.56 ( 14.227 )
    -0.42 ( 19.384 )
        Week 2 (N=5, 14)
    20.56 ( 27.744 )
    0.76 ( 14.792 )
        Week 3 (N=5, 12)
    18.70 ( 15.566 )
    8.05 ( 14.490 )
        Week 4 (N=5, 11)
    14.06 ( 11.631 )
    8.88 ( 15.866 )
        Week 5 (N=4, 12)
    -3.28 ( 6.338 )
    2.30 ( 17.768 )
        Week 6 (N=4, 12)
    3.28 ( 11.261 )
    6.73 ( 17.272 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Subjective Sleep Related Impairment (PROMIS-Pediatric- Sleep-Related Impairment [SRI])

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    End point title
    Change From Baseline in Subjective Sleep Related Impairment (PROMIS-Pediatric- Sleep-Related Impairment [SRI])
    End point description
    Change from baseline in PROMIS-Pediatric-SRI were reported. The PROMIS-SRI 8 items score was used to assess self-reported daytime perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness and assessed on a 5 level Likert-type scale. The 8-item short form used in this study, scored 1 to 5 for each item. For the 8-item form, the lowest possible raw score is 8; the highest possible raw score is 39. Total raw score for a short form with all questions answered equals sum of the values of response to each question. Higher overall score indicated more sleep disturbance. Safety analysis set included all randomised subjects who took at least 1 dose of study intervention. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and end of double-blind phase (Week 6)
    End point values
    Placebo Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    6
    22
    Units: units on a scale
        arithmetic mean (standard deviation)
    -12.12 ( 8.055 )
    -6.60 ( 7.616 )
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Seltorexant and an Active Metabolite of Seltorexant

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    End point title
    Plasma Concentration of Seltorexant and an Active Metabolite of Seltorexant [11]
    End point description
    Plasma concentration of seltorexant and an active metabolite of seltorexant were reported. Population analysed included all subjects who received study intervention and had at least 1 plasma concentration data value after study intervention intake. Here "N" (Number of subjects analysed) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 8 to 14 hours post last dose in Week 6
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for the specified arms only
    End point values
    Seltorexant 10 mg and 20 mg
    Number of subjects analysed
    12
    Units: nanograms per millilitre (ng/mL)
    arithmetic mean (standard deviation)
        Total Seltorexant
    42.7 ( 52.8 )
        Active metabolite
    54.5 ( 53.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of treatment (Day 1) up to end of double-blind phase (Week 6)
    Adverse event reporting additional description
    Safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Seltorexant 10 mg and 20 mg
    Reporting group description
    Subjects with body weight greater than or equal to (>=) 45 kilograms (kg) received a single oral dose of seltorexant 20 milligrams (mg) tablet once daily at bedtime and subjects with body weight >=30 kg to less than (<) 45 kg received seltorexant 10 mg tablet once daily at bedtime from Day 1 to Week 6. Subjects continued with their baseline SSRI antidepressant (fluoxetine or escitalopram) treatment at same dose as it was prior to entering the study.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single oral dose of placebo (matching to seltorexant) tablet once daily at bedtime from Day 1 to Week 6.

    Serious adverse events
    Seltorexant 10 mg and 20 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Seltorexant 10 mg and 20 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 23 (26.09%)
    2 / 7 (28.57%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    Nausea
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 7 (14.29%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Mar 2023
    The purpose of the protocol amendment dated 27-Mar-2023 was to align the protocol criteria more with current clinical practices and to increase feasibility of the study conduct. Due to subject feedback to sites regarding length and number of visits, adjustments were made to the visits as noted in the protocol amendment to allow for visit flexibility through remote assessment.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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