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    Clinical Trial Results:
    A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Treatment Resistant Unipolar Major Depressive Disorder (MDD)

    Summary
    EudraCT number
    		 2015-001456-29
    Trial protocol
    		 DE  
    Global end of trial date
    07 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2022
    First version publication date
    21 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Mino-TRD(OptiMD)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité University Medicine Berlin
    Sponsor organisation address
    Hindenburgdamm 30, Berlin, Germany, 12203
    Public contact
    Charité - Campus Benjamin Franklin, Institut Klinik für Psychiatrie und Psychotherapie, +49 30450 517522, isabella.heuser@charite.de
    Scientific contact
    Charité - Campus Benjamin Franklin, Institut Klinik für Psychiatrie und Psychotherapie, +49 30450 517522, isabella.heuser@charite.de
    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
    07 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Change in the MADRS value from starting point (week 1) to last visit (week 7), with weekly visits Time point of determination of primary target parameters (objective): week 1-6, 7, 6 week after and 6 months after last visit
    Protection of trial subjects
    Routine lab safety measurements were performed in addition to clinical interviews, where AEs were assessed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2015
    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
    Germany: 168
    Worldwide total number of subjects
    168
    EEA total number of subjects
    168
    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)
    168
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 9 study centers in 1 country,7. Januar 2016 - 7. August 2020

    Pre-assignment
    Screening details
    		 A total of 253 subjects entered the screening period, of whom 85 withdrew before randomization. The remaining 168 subjects were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Minocycline
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Minocycline Hydrochloride dihydrate
    Investigational medicinal product code
    10118-90-8
    Other name
    Udima
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects Minocycline Hydrochloride dihydrate capsule orally for 7 weeks (daily, weekly...??)

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    6 weeks 2X2 200mg Placebo

    Number of subjects in period 1
    		Minocycline Placebo
    Started
    81
    87
    Completed
    69
    75
    Not completed
    12
    12
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    6
    2
         Physician decision
    3
    2
         N/A
    -
    4
         Adverse event, non-fatal
    1
    1
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Minocycline
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Minocycline Placebo Total
    Number of subjects
    		 81 87 168
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.8 ( 13.6 ) 47.3 ( 12.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 31 48 79
        Male
    		 50 39 89
    MADRS
    MADRS=Montgomery–Åsberg Depression Rating Scale
    Units: Score
        arithmetic mean (standard deviation)
    		 26.4 ( 4.8 ) 26.6 ( 5.1 ) -
    HAMD-17
    AM-D-17=Hamilton Depression Rating Scale
    Units: Score
        arithmetic mean (standard deviation)
    		 20.0 ( 3.5 ) 20.3 ( 3.5 ) -
    BDI II
    BDI-II=Beck Depression Inventory
    Units: Score
        arithmetic mean (standard deviation)
    		 32.3 ( 9.0 ) 32.9 ( 10.4 ) -
    SCL-90-RGSI
    SCL-90-R= Symptom Checklist-90-R
    Units: Score
        arithmetic mean (standard deviation)
    		 68.7 ( 6.8 ) 66.9 ( 6.9 ) -
    CGI
    GSI Global Severity Index
    Units: Score
        arithmetic mean (standard deviation)
    		 4.8 ( 0.6 ) 4.9 ( 0.7 ) -
    TMT-A
    TMT = trail making test
    Units: Score
        arithmetic mean (standard deviation)
    		 34.7 ( 16.6 ) 35.1 ( 14.3 ) -
    TMT-B
    Units: Score
        arithmetic mean (standard deviation)
    		 77.5 ( 32.7 ) 76.1 ( 32.3 ) -
    CRP
    C-reactive protein
    Units: milligram(s)/litre
        arithmetic mean (full range (min-max))
    		 1.21 (0.02 to 22.10) 0.6 (0.05 to 7.30) -
    SCL-PSDI
    Positive Symptom Distress Index
    Units: Score
        arithmetic mean (standard deviation)
    		 66.3 ( 4.9 ) 66.1 ( 6.0 ) -
    SCL-PST
    Positive Symptom Total
    Units: Score
        arithmetic mean (standard deviation)
    		 64.4 ( 6.6 ) 62.2 ( 6.0 ) -

    End points

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    End points reporting groups
    Reporting group title
    Minocycline
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change of MADRS baseline - week 7

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    End point title
    		 Change of MADRS baseline - week 7
    End point description
    End point type
    Primary
    End point timeframe
    MADRS scores were assessed at baseline and throughout week 7, change in MADRS score was calculated for the 6 week treatment period
    End point values
    		 Minocycline Placebo
    Number of subjects analysed
    69
    75
    Units: points
        arithmetic mean (standard deviation)
    17.6 ( 7.8 )
    18.7 ( 9.0 )
    Statistical analysis title
    		 Change of the MADRS sum score
    Comparison groups
    Minocycline v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
         level
    		 95%

    Secondary: Post-treatment BDI

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    End point title
    		 Post-treatment BDI
    End point description
    BDI II = Beck’s depression inventory Version II
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Minocycline Placebo
    Number of subjects analysed
    66
    72
    Units: Score
    arithmetic mean (standard deviation)
        BDI
    21.6 ( 12.0 )
    23.6 ( 13.2 )
    No statistical analyses for this end point

    Secondary: Post-treatment CGI

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    End point title
    		 Post-treatment CGI
    End point description
    clinical global impression scale
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Minocycline Placebo
    Number of subjects analysed
    69
    75
    Units: Score
    arithmetic mean (standard deviation)
        CGI
    3.9 ( 1.1 )
    4.0 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Post-treatment HAMD 6

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    End point title
    		 Post-treatment HAMD 6
    End point description
    HAMD = Hamilton Depression Rating Scale
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Minocycline Placebo
    Number of subjects analysed
    69
    71
    Units: Score
    arithmetic mean (standard deviation)
        HAMD6
    7.4 ( 3.5 )
    7.6 ( 6.7 )
    No statistical analyses for this end point

    Secondary: Post-treatment HAMD 17

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    End point title
    		 Post-treatment HAMD 17
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Minocycline Placebo
    Number of subjects analysed
    68
    71
    Units: Score
    arithmetic mean (standard deviation)
        HAMD 17
    13.1 ( 5.9 )
    14.2 ( 6.7 )
    No statistical analyses for this end point

    Secondary: Post-treatment SCL-90

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    End point title
    		 Post-treatment SCL-90
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Minocycline Placebo
    Number of subjects analysed
    66
    72
    Units: Score
    arithmetic mean (standard deviation)
        GSI
    62.3 ( 10.7 )
    62.0 ( 10.1 )
        PSDI
    60.2 ( 8.3 )
    60.2 ( 8.9 )
        PST
    60.5 ( 10.1 )
    59.5 ( 8.9 )
    No statistical analyses for this end point

    Secondary: Post-treatment trail making test

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    End point title
    		 Post-treatment trail making test
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Minocycline Placebo
    Number of subjects analysed
    69
    74
    Units: Score
    arithmetic mean (standard deviation)
        TMT-A
    29.9 ( 12.2 )
    30.4 ( 14.1 )
        TMT-B
    68.1 ( 27.6 )
    68.8 ( 29.1 )
    No statistical analyses for this end point

    Secondary: Post-treatment Log CRP

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    End point title
    		 Post-treatment Log CRP
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Minocycline Placebo
    Number of subjects analysed
    66
    69
    Units: milligram(s)/litre
    arithmetic mean (standard deviation)
        CRP
    1.77 ( 0.29 )
    1.82 ( 0.28 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Minocycline
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Minocycline Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 81 (7.41%)
    8 / 87 (9.20%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Colon-Ca; CEA- Increase
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumormarkerbefund
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    cheekbone fracture
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    drunk bicycle accident
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Zerebrale Aneurysmablutung
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Eosinophilie
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Cholezystektomie
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    biliäre Pankreatitis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 81 (3.70%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Minocycline Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 81 (82.72%)
    63 / 87 (72.41%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 81 (20.99%)
    27 / 87 (31.03%)
         occurrences all number
    33
    43
    Dizziness
         subjects affected / exposed
    15 / 81 (18.52%)
    5 / 87 (5.75%)
         occurrences all number
    20
    7
    Tremor
         subjects affected / exposed
    3 / 81 (3.70%)
    0 / 87 (0.00%)
         occurrences all number
    5
    0
    General disorders and administration site conditions
    Tiredness
         subjects affected / exposed
    9 / 81 (11.11%)
    6 / 87 (6.90%)
         occurrences all number
    11
    9
    Hyperhidrosis
         subjects affected / exposed
    3 / 81 (3.70%)
    6 / 87 (6.90%)
         occurrences all number
    4
    6
    Gastrointestinal disorders
    Dyspepsia/Indigestion
         subjects affected / exposed
    14 / 81 (17.28%)
    14 / 87 (16.09%)
         occurrences all number
    25
    19
    Flatulence/Diarrhoea
         subjects affected / exposed
    12 / 81 (14.81%)
    14 / 87 (16.09%)
         occurrences all number
    15
    26
    Nausea
         subjects affected / exposed
    8 / 81 (9.88%)
    11 / 87 (12.64%)
         occurrences all number
    12
    12
    Skin and subcutaneous tissue disorders
    Exanthem; Erythem, Akne
         subjects affected / exposed
    10 / 81 (12.35%)
    10 / 87 (11.49%)
         occurrences all number
    11
    11
    Psychiatric disorders
    Depression/Extracerbation
         subjects affected / exposed
    8 / 81 (9.88%)
    9 / 87 (10.34%)
         occurrences all number
    10
    10
    Insomnia
         subjects affected / exposed
    2 / 81 (2.47%)
    6 / 87 (6.90%)
         occurrences all number
    4
    9
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 81 (7.41%)
    6 / 87 (6.90%)
         occurrences all number
    6
    6
    Infections and infestations
    flu-like symptoms
         subjects affected / exposed
    24 / 81 (29.63%)
    13 / 87 (14.94%)
         occurrences all number
    30
    16
    Vaginal fungal infection
         subjects affected / exposed
    3 / 81 (3.70%)
    1 / 87 (1.15%)
         occurrences all number
    5
    1

    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.
    None reported
    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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