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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients with Major Depressive Disorder

    Summary
    EudraCT number
    		 2018-000060-29
    Trial protocol
    		 HU   SK   PL  
    Global end of trial date
    11 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jul 2020
    First version publication date
    26 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RAP-MD-30
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03675776
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan
    Sponsor organisation address
    1st Floor, Marlow International, The Parkway, Marlow, Buckinghamshire, United Kingdom, SL7 1YL
    Public contact
    Clinical Trials Registry Team, Allergan plc, 001 877‐277‐8566, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan, 001 862-261-7000, IR-CTRegistration@Allergan.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    11 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this trial is to evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 24
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Russian Federation: 3
    Country: Number of subjects enrolled
    Slovakia: 7
    Country: Number of subjects enrolled
    Hungary: 15
    Worldwide total number of subjects
    50
    EEA total number of subjects
    23
    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)
    0
    Adults (18-64 years)
    49
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 68 participants were screened for eligibility; 50 participants randomized to receive double-blind treatment.

    Period 1
    Period 1 title
    Double Blind Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo (prefilled syringe, weekly IV administration).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous IV administration

    Arm title
    		 Rapastinel 225mg
    Arm description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rapastinel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rapastinel intravenous IV administration

    Arm title
    		 Rapastinel 450mg
    Arm description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rapastinel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rapastinel intravenous IV administration

    Number of subjects in period 1
    		Placebo Rapastinel 225mg Rapastinel 450mg
    Started
    15
    17
    18
    Completed
    9
    11
    10
    Not completed
    6
    6
    8
         Study Terminated by Sponsor
    5
    6
    8
         Lack of efficacy
    1
    -
    -
    Period 2
    Period 2 title
    Safety Follow-Up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo (prefilled syringe, weekly IV administration).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous IV administration

    Arm title
    		 Rapastinel 225mg
    Arm description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rapastinel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rapastinel intravenous IV administration

    Arm title
    		 Rapastinel 450mg
    Arm description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rapastinel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rapastinel intravenous IV administration

    Number of subjects in period 2 [1]
    		Placebo Rapastinel 225mg Rapastinel 450mg
    Started
    6
    8
    7
    Completed
    6
    8
    7
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Nine patients who entered the extension study (RAP-MD-33) did not enter the Safety Follow Up Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (prefilled syringe, weekly IV administration).

    Reporting group title
    Rapastinel 225mg
    Reporting group description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).

    Reporting group title
    Rapastinel 450mg
    Reporting group description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).

    Reporting group values
    		 Placebo Rapastinel 225mg Rapastinel 450mg Total
    Number of subjects
    		 15 17 18 50
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 15 16 18 49
        From 65-84 years
    		 0 1 0 1
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.4 ( 10.36 ) 44.7 ( 10.83 ) 43.2 ( 11.06 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 7 13 7 27
        Male
    		 8 4 11 23
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 7 10 9 26
        Black or African American
    		 0 0 0 0
        Asian
    		 8 7 9 24
        Hispanic
    		 0 0 0 0
    Montgomery-Asberg Depression Rating Scale (MADRS)
    The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    		 34.5 ( 4.34 ) 35.2 ( 4.78 ) 34.8 ( 4.72 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (prefilled syringe, weekly IV administration).

    Reporting group title
    Rapastinel 225mg
    Reporting group description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).

    Reporting group title
    Rapastinel 450mg
    Reporting group description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (prefilled syringe, weekly IV administration).

    Reporting group title
    Rapastinel 225mg
    Reporting group description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).

    Reporting group title
    Rapastinel 450mg
    Reporting group description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).

    Primary: Change from Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) total score at end of double-blind treatment (end of week 6).

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    End point title
    		 Change from Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) total score at end of double-blind treatment (end of week 6). [1]
    End point description
    The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement
    End point type
    Primary
    End point timeframe
    Baseline to end of 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: No inferential statistical analyses were performed for the efficacy parameters.
    End point values
    		 Placebo Rapastinel 225mg Rapastinel 450mg
    Number of subjects analysed
    9
    11
    10
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -11.3 ( 9.06 )
    -21.3 ( 10.31 )
    -12.9 ( 11.36 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in MADRS total score at 1 Day after first dose of treatment

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    End point title
    		 Change from Baseline in MADRS total score at 1 Day after first dose of treatment
    End point description
    The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to 1 Day post-first dose
    End point values
    		 Placebo Rapastinel 225mg Rapastinel 450mg
    Number of subjects analysed
    15
    17
    18
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -6.7 ( 5.36 )
    -7.4 ( 9.10 )
    -6.4 ( 9.11 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period.
    Adverse event reporting additional description
    Safety Population consisted of all randomized patients who received at least 1 dose of randomized investigational product (IP).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (prefilled syringe, weekly IV administration).

    Reporting group title
    Rapastinel 225mg
    Reporting group description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).

    Reporting group title
    Rapastinel 450mg
    Reporting group description
    		 Rapastinel (prefilled syringe, weekly intravenous IV administration).

    Serious adverse events
    		 Placebo Rapastinel 225mg Rapastinel 450mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Rapastinel 225mg Rapastinel 450mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 15 (40.00%)
    1 / 17 (5.88%)
    6 / 18 (33.33%)
    Investigations
    Blood triglycerides increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Glucose urine present
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Feeling abnormal
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Drug Withdrawal Syndrome
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Hallucination
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Due to study termination, the target number of participants needed to achieve target power and statistically reliable results was not met.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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