Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    International randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate

    Summary
    EudraCT number
    		 2010-023992-24
    Trial protocol
    		 DE   ES   BE   HU  
    Global end of trial date
    08 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2020
    First version publication date
    23 Jul 2020
    Other versions
    Summary report(s)
    		 Synopsis MEMAP acc. to ICH E3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MEMAP1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01541605
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universität Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany, 04109
    Public contact
    Prof. Dr. Ulrich Hegerl, Department of Psychiatry and Psychotherapy, 49 341 9724530, Ulrich.Hegerl@medizin.uni-leipzig.de
    Scientific contact
    Prof. Dr. Ulrich Hegerl, Department of Psychiatry and Psychotherapy, 49 341 9724530, Ulrich.Hegerl@medizin.uni-leipzig.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
    18 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test the hypothesis that methylphenidate immediate release given twice daily (BID) is significantly superior to placebo in the treatment of manic symptoms in patients with bipolar disorder after 2.5 days of treatment as assessed by the Young Mania Rating Scale (YMRS).
    Protection of trial subjects
    Patients were closely monitored by the treating staff with regard to safety during the course of the trial. This included documentation of (S)AEs as well as trial specific safety parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Aug 2012
    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: 23
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Germany: 17
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    40
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 42 patients were recruited for the MEMAP trial

    Pre-assignment
    Screening details
    		 NO screening period

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Placebo controlled trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Methylphenidate
    Arm description
    		 2.5 day treatment with methylphenidate BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Medikinet
    Investigational medicinal product code
    54569.00.00, 6620412.00.00, 54569.01.00
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 day treatment with methylphenidate. Medication will be administered at 10.00 and 15.00 h on day 0 - 15 mg methylphenidate at 09.00 and 15.00 h on day 1 - 20 mg methylphenidate at 09.00 h on day 2 - 20 mg methylphenidate

    Arm title
    		 Placebo
    Arm description
    		 placebo treatment
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    twice daily

    Number of subjects in period 1
    		Methylphenidate Placebo
    Started
    22
    20
    Completed
    22
    20

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Methylphenidate
    Reporting group description
    		 2.5 day treatment with methylphenidate BID

    Reporting group title
    Placebo
    Reporting group description
    		 placebo treatment

    Reporting group values
    		 Methylphenidate Placebo Total
    Number of subjects
    		 22 20 42
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 22 18 40
        From 65-84 years
    		 0 2 2
        85 years and over
    		 0 0 0
        Adults
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 11 20
        Male
    		 13 9 22
    Subject analysis sets

    Subject analysis set title
    Intention-To-Treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomized, who got at least one dosage of treatment regardless of protocol violations.

    Subject analysis sets values
    		 Intention-To-Treat
    Number of subjects
    42
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    40
        From 65-84 years
    2
        85 years and over
        Adults
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    20
        Male
    22

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Methylphenidate
    Reporting group description
    		 2.5 day treatment with methylphenidate BID

    Reporting group title
    Placebo
    Reporting group description
    		 placebo treatment

    Subject analysis set title
    Intention-To-Treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomized, who got at least one dosage of treatment regardless of protocol violations.

    Primary: YMRS: severity of manic symptoms

    		 Close Top of page
    End point title
    		 YMRS: severity of manic symptoms [1]
    End point description
    The primary efficacy measure in this study was the severity of manic symptoms as measured by a clinician-administered mania rating scale, the Young Mania Rating Scale (YMRS) (Young et al, 1978). A YMRS sum score of at least 12 points reflects mania (for further details see Kluge et al, 2013). The primary endpoint was determined after 2.5 days of treatment with methylphenidate or placebo. Analysis of covariance (ANCOVA) was computed in order to analyze differences between methylphenidate and placebo regarding the primary outcome (the mean change from baseline in the sum score of the YMRS at day 2.5), with gender, age and the severity of mania (as reflected by the YMRS total score at baseline) being the covariates.
    End point type
    Primary
    End point timeframe
    day 0 to day 2.5 of treatment
    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: The complete statistical analysis can be found in the publication (see link) and in the trial synopsis, uploaded together with the results report.
    End point values
    		 Methylphenidate Placebo
    Number of subjects analysed
    22
    20
    Units: Score
        arithmetic mean (standard deviation)
    5.07 ± 11.44
    7.82 ± 6.42
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    start of treatment until day 9 follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Methylphenidate
    Reporting group description
    		 Treatment with Methylphenidate

    Reporting group title
    Placebo
    Reporting group description
    		 Patients treated with placebo

    Serious adverse events
    		 Methylphenidate Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Methylphenidate Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 22 (40.91%)
    2 / 20 (10.00%)
    Vascular disorders
    Hypertension aggravated
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Paraesthesia of scalp
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Tardive dyskinesia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Edema face
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Skin rough
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Mental lability symptom
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Mania aggravated
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Mania
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Stiffness
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2013
    new trial site change in selection criteria
    24 Oct 2013
    extension of trial duration
    31 Jul 2014
    change in trial staff extension of trial duration
    24 Jul 2015
    addition of a new trial site

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29174864
    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.

    European Medicines Agency © 1995-Sun May 05 21:22:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA