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    Clinical Trial Results:
    A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (5.0 mg or 2.5 mg) of MIN-117 in Adult Patients with Major Depressive Disorder

    Summary
    EudraCT number
    		 2017-005149-64
    Trial protocol
    		 FI   PL   BG  
    Global end of trial date
    13 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2020
    First version publication date
    06 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MIN-117C03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03446846
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Minerva Neurosciences, Inc.
    Sponsor organisation address
    1601 Trapelo Road, Suite 286, Waltham, United States, 02451
    Public contact
    Joseph Reilly, Minerva Neurosciences, Inc., 1 6176007380, jsaoud@minervaneurosciences.com
    Scientific contact
    Jay Saoud, Minerva Neurosciences, Inc., 1 6176007375, jreilly@minervaneurosciences.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
    10 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 2 fixed doses (5.0 mg or 2.5 mg) of MIN-117 compared with placebo in reducing the symptoms of major depression measured by the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score over 6 weeks of treatment in adult patients with major depressive disorder (MDD).
    Protection of trial subjects
    Prior to initiation of the study, the study protocol and associated documentation were reviewed and approved by an Independent Ethics Committee (IEC). This study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practices (GCP) and applicable regulatory requirements. Patients provided their written consent to participate in the study after having been informed about the nature and purpose of the study, participation/termination conditions, and risks and benefits of treatment. Personal data from subjects enrolled in this study was limited to those data necessary to investigate the efficacy, safety, quality, and utility of the investigational study drug(s) used in this study, and were collected and processed with adequate precautions to ensure confidentiality and compliance with applicable data privacy protection laws and regulations. Safety and tolerability assessments were evaluated by an analysis of AEs throughout the study, and vital signs, ECGs, physical and neurological examinations, and clinical laboratory tests at specified time points during the study.
    Background therapy
    		 Women were to remain on a highly effective method of birth control for the duration of the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2018
    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
    Poland: 52
    Country: Number of subjects enrolled
    Bulgaria: 78
    Country: Number of subjects enrolled
    Finland: 55
    Country: Number of subjects enrolled
    United States: 46
    Country: Number of subjects enrolled
    Ukraine: 111
    Country: Number of subjects enrolled
    Georgia: 15
    Country: Number of subjects enrolled
    Moldova, Republic of: 3
    Worldwide total number of subjects
    360
    EEA total number of subjects
    185
    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)
    350
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrolled patients were recruited at study centers in 7 countries (Ukraine, Bulgaria, United States, Poland, Finland, Georgia, and Moldova).

    Pre-assignment
    Screening details
    		 Patients were screened for eligibility to participate in the study within 21 days before dosing.

    Period 1
    Period 1 title
    Patient Disposition - ITT Population
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Study drugs were packaged using a double-dummy, double-blind design.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo (ITT)
    Arm description
    		 Patients received Placebo every day for 6 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received Placebo as a daily dose consisting of 2 capsules containing the intended dose (placebo).

    Arm title
    		 2.5 mg MIN-117 (ITT)
    Arm description
    		 Patients received 2.5 mg MIN-117 every day for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIN-117
    Investigational medicinal product code
    MIN-117
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2.5 mg MIN-117 as a daily dose consisting of 2 capsules containing the intended dose (1 capsule of 2.5 mg MIN-117 and 1 capsule of Placebo).

    Arm title
    		 5.0 mg MIN-117 (ITT)
    Arm description
    		 Patients received 5.0 mg MIN-117 every day for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIN-117
    Investigational medicinal product code
    MIN-117
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 5.0 mg MIN-117 as a daily dose consisting of 2 capsules containing the intended dose (2 capsules of 2.5 mg MIN-117).

    Number of subjects in period 1
    		Placebo (ITT) 2.5 mg MIN-117 (ITT) 5.0 mg MIN-117 (ITT)
    Started
    178
    92
    90
    Completed
    162
    87
    83
    Not completed
    16
    5
    7
         Consent withdrawn by subject
    11
    2
    5
         Noncompliance with study drug
    2
    1
    1
         Lost to follow-up
    3
    2
    1
    Period 2
    Period 2 title
    Safety Population
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Study drugs were packaged using a double-dummy, double-blind design.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo (Safety Population)
    Arm description
    		 Patients received Placebo every day for 6 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received Placebo as a daily dose consisting of 2 capsules containing the intended dose (placebo).

    Arm title
    		 2.5 mg MIN-117 (Safety Population)
    Arm description
    		 Patients received 2.5 mg MIN-117 every day for 6 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIN-117
    Investigational medicinal product code
    MIN-117
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2.5 mg MIN-117 as a daily dose consisting of 2 capsules containing the intended dose (1 capsule of 2.5 mg MIN-117 and 1 capsule of Placebo).

    Arm title
    		 5.0 mg MIN-117 (Safety Population)
    Arm description
    		 Patients received 5.0 mg MIN-117 every day for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIN-117
    Investigational medicinal product code
    MIN-117
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 5.0 mg MIN-117 as a daily dose consisting of 2 capsules containing the intended dose (2 capsules of 2.5 mg MIN-117).

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: One patient was randomized to a particular kit# in the Electronic Data Capture system, however, the site dispensed another kit# instead in error. Consequently, the patient was randomized to placebo but received 5.0 mg MIN-117 and was, therefore, included in the (Intent-to-Treat) ITT population based on the randomized treatment to placebo and in the safety population based on the actual treatment they received (5.0 mg MIN-117). Period 1 (ITT) created to support Baseline Characteristics entry.
    Number of subjects in period 2
    		Placebo (Safety Population) 2.5 mg MIN-117 (Safety Population) 5.0 mg MIN-117 (Safety Population)
    Started
    177
    92
    91
    Completed
    161
    87
    84
    Not completed
    16
    5
    7
         Consent withdrawn by subject
    11
    2
    5
         Noncompliance with study drug
    2
    1
    1
         Lost to follow-up
    3
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (Safety Population)
    Reporting group description
    		 Patients received Placebo every day for 6 weeks.

    Reporting group title
    2.5 mg MIN-117 (Safety Population)
    Reporting group description
    		 Patients received 2.5 mg MIN-117 every day for 6 weeks

    Reporting group title
    5.0 mg MIN-117 (Safety Population)
    Reporting group description
    		 Patients received 5.0 mg MIN-117 every day for 6 weeks.

    Reporting group values
    		 Placebo (Safety Population) 2.5 mg MIN-117 (Safety Population) 5.0 mg MIN-117 (Safety Population) Total
    Number of subjects
    		 177 92 91 360
    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)
    		 171 90 89 350
        From 65-84 years
    		 6 2 2 10
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ( 12.5 ) 47 ( 12.7 ) 48 ( 11.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 136 60 62 258
        Male
    		 41 32 29 102
    Race
    Units: Subjects
        White
    		 165 87 85 337
        Black or African American
    		 11 4 5 20
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Asian
    		 1 1 1 3
        American Indian or Alaska Native
    		 0 0 0 0
    Subject analysis sets

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population is the population of all patients who received at least 1 dose of study treatment. Patients in this population were analyzed according to the treatment they received, regardless of which treatment they were randomly assigned.

    Subject analysis sets values
    		 Safety Population
    Number of subjects
    360
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    350
        From 65-84 years
    10
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    48 ( 12.3 )
    Gender categorical
    Units: Subjects
        Female
    258
        Male
    102
    Race
    Units: Subjects
        White
    337
        Black or African American
    20
        Native Hawaiian or Other Pacific Islander
    0
        Asian
    3
        American Indian or Alaska Native
    0

    End points

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    End points reporting groups
    Reporting group title
    Placebo (ITT)
    Reporting group description
    		 Patients received Placebo every day for 6 weeks.

    Reporting group title
    2.5 mg MIN-117 (ITT)
    Reporting group description
    		 Patients received 2.5 mg MIN-117 every day for 6 weeks.

    Reporting group title
    5.0 mg MIN-117 (ITT)
    Reporting group description
    		 Patients received 5.0 mg MIN-117 every day for 6 weeks.
    Reporting group title
    Placebo (Safety Population)
    Reporting group description
    		 Patients received Placebo every day for 6 weeks.

    Reporting group title
    2.5 mg MIN-117 (Safety Population)
    Reporting group description
    		 Patients received 2.5 mg MIN-117 every day for 6 weeks

    Reporting group title
    5.0 mg MIN-117 (Safety Population)
    Reporting group description
    		 Patients received 5.0 mg MIN-117 every day for 6 weeks.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population is the population of all patients who received at least 1 dose of study treatment. Patients in this population were analyzed according to the treatment they received, regardless of which treatment they were randomly assigned.

    Primary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

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    End point title
    		 Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
    End point description
    The Montgomery-Asberg Depression Rating Scale (MADRS) is a validated, physician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. The test exhibits high inter-rater reliability and its capacity to differentiate between responders and nonresponders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression.
    End point type
    Primary
    End point timeframe
    Week 6
    End point values
    		 Placebo (ITT) 2.5 mg MIN-117 (ITT) 5.0 mg MIN-117 (ITT)
    Number of subjects analysed
    149
    76
    70
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -12 ( 9.2 )
    -12 ( 9.2 )
    -12 ( 9.2 )
    Statistical analysis title
    		 Statistical Analysis - Primary Endpoint
    Statistical analysis description
    The adjustment for multiplicity within the family of primary hypotheses will utilize the Hochberg procedure for the purpose of reporting of results.
    Comparison groups
    Placebo (ITT) v 2.5 mg MIN-117 (ITT) v 5.0 mg MIN-117 (ITT)
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Hochberg procedure
    Confidence interval

    Secondary: Change in Hamilton Anxiety Scale (HAM-A)

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    End point title
    		 Change in Hamilton Anxiety Scale (HAM-A)
    End point description
    Hamilton Anxiety Scale (HAM-A) measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. The participant is asked to rate the gravity of each item using a 5-level scale, from 0 to 4, with 4 being the most severe, and afterwards the results are collated and tabulated to determine the severity of anxiety.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo (ITT) 2.5 mg MIN-117 (ITT) 5.0 mg MIN-117 (ITT)
    Number of subjects analysed
    149
    76
    70
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -11 ( 8.5 )
    -11 ( 9.1 )
    -12 ( 8.0 )
    No statistical analyses for this end point

    Secondary: Change in Clinical Global Impression of Severity Scale (CGI-S)

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    End point title
    		 Change in Clinical Global Impression of Severity Scale (CGI-S)
    End point description
    The Clinical Global Impression of Severity (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" which is rated on the following scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The CGI-S will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo (ITT) 2.5 mg MIN-117 (ITT) 5.0 mg MIN-117 (ITT)
    Number of subjects analysed
    149
    76
    70
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -1 ( 1.2 )
    -1 ( 1.1 )
    -1 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Change in Clinical Global Impression of Improvement Scale (CGI-I)

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    End point title
    		 Change in Clinical Global Impression of Improvement Scale (CGI-I)
    End point description
    The Clinical Global Impression of Improvement Scale (CGI-I) will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-I consists of a 7-point scale that evaluates the change from initiation of treatment similar to the Clinical Global Impression of Severity Scale (CGI-S).
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo (ITT) 2.5 mg MIN-117 (ITT) 5.0 mg MIN-117 (ITT)
    Number of subjects analysed
    149
    76
    70
    Units: Score on a scale
        arithmetic mean (standard deviation)
    3 ( 1.1 )
    3 ( 1.2 )
    3 ( 1.0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately up to 11 weeks
    Adverse event reporting additional description
    Treatment-emergent adverse events were those that were reported on or after the initiation of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients received Placebo every day for 6 weeks.

    Reporting group title
    2.5 mg MIN-117
    Reporting group description
    		 Patients received 2.5 mg MIN-117 every day for 6 weeks.

    Reporting group title
    5.0 mg MIN-117
    Reporting group description
    		 Patients received 5.0 mg MIN-117 every day for 6 weeks.

    Serious adverse events
    		 Placebo 2.5 mg MIN-117 5.0 mg MIN-117
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 92 (1.09%)
    0 / 91 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Psychiatric disorders
    Feeling guilty
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 92 (1.09%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 92 (1.09%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 92 (1.09%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 2.5 mg MIN-117 5.0 mg MIN-117
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 177 (7.34%)
    11 / 92 (11.96%)
    11 / 91 (12.09%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 177 (7.34%)
    11 / 92 (11.96%)
    11 / 91 (12.09%)
         occurrences all number
    13
    11
    11

    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.
    No notable study limitations were identified.
    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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