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    Clinical Trial Results:
    Genetic modulation of functional brain activity of attention-deficit/hyperactivity disorder-related working memory processes

    Summary
    EudraCT number
    		 2008-006242-26
    Trial protocol
    		 DE  
    Global end of trial date
    23 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    W004PS0108 2.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01351272
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Würzburg
    Sponsor organisation address
    Josef-Schneider-Str. 2, Würzburg, Germany, 97080
    Public contact
    Prof. Dr. Jürgen Deckert, Klinik für Psychiatrie, Psychosomatik und Psychotherapie, 0049 93120177000, Deckert_J@ukw.de
    Scientific contact
    Prof. Dr. Martin Herrmann, Klinik für Psychiatrie, Psychosomatik und Psychotherapie, 0049 93120176650, Herrmann_m@ukw.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
    31 Dec 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1: To examine the modulation of the functional brain activity during working memory processes by therapeutic methylphenidate administration in ADHD patients 2: To examine the clinical improvement of ADHD symptoms and general functioning by therapeutic methylphenidate administration in ADHD patients
    Protection of trial subjects
    Patients were seen at least two-weekly by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). Once a year (starting with the date of the first authorisation by the competent authority) throughout the trial a safety report according to § 13 (6) GCP-V and “Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use, Rev. 2, April 2006” has been submitted to the competent authority and the Ethics Committee.
    Background therapy
    		 none
    Evidence for comparator
    		 The treatment with the stimulant methylphenidate has a clinical effect in children, adolescent and adults with ADHD (Smith et al., 2000; Schachter et al., 2001; Faraone et al., 2004) and is therefore the first-line treatment for ADHD. The therapeutic administration of MPH in ADHD patients over four weeks seems to improve response inhibition as well as working memory task performance (Coghill et al., 2007) and recognition memory (Rhodes et al., 2004). A recent positron emission tomography (PET) study (Schweitzer et al., 2004) showed that optimal therapeutic administration of MPH over three weeks improves the working memory performance of ADHD patients and reduces the rCBF in the prefrontal cortex. In an randomized, placebo-controlled study over 6 weeks (Bush et al., 2008) a normalisation of the dorsal anterior midcingulate cortex activity during an Multi-Source Interference Task in the methylphenidate group has been found.
    Actual start date of recruitment
    05 Apr 2011
    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
    Germany: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    41
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of clinical trial start: 05.04.2011 (first visit of first patient (FVFP)) Date of last patient: 10/2012

    Pre-assignment
    Screening details
    		 The proposed study was conducted in a group of patients with Attention-Deficit/Hyperactivity Disorder (ADHD) (DSM-IV diagnoses: 314.xx), who were admitted to psychiatric out- or inpatient treatment at the University Hospital of Würzburg, Department of Psychiatry, Psychosomatics and Psychotherapy.

    Pre-assignment period milestones
    Number of subjects started
    		 41
    Number of subjects completed
    		 35

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 6
    Period 1
    Period 1 title
    prefMRI
    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
    		 Placebo administration Within this double blind study the same procedure as described for Methylphenidat-HCl was applied for the placebo condition.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    o
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Within this double blind study the same procedure as described for Methylphenidat-HCl was applied for the placebo condition.

    Arm title
    		 Methylphenidate, non-retard
    Arm description
    		 Drug: Methylphenidate, non-retard Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylphenidat-HCl
    Investigational medicinal product code
    N06BA04
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg.

    Number of subjects in period 1 [1]
    		Placebo Methylphenidate, non-retard
    Started
    16
    19
    Completed
    16
    19
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 6 patients were excluded out after informed consent were given
    Period 2
    Period 2 title
    postfMRI
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo administration Within this double blind study the same procedure as described for Methylphenidat-HCl was applied for the placebo condition.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg.

    Arm title
    		 Methylphenidate, non-retard
    Arm description
    		 Drug: Methylphenidate, non-retard Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylphenidat-HCl
    Investigational medicinal product code
    N06BA04
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg.

    Number of subjects in period 2
    		Placebo Methylphenidate, non-retard
    Started
    16
    19
    Completed
    13
    14
    Not completed
    3
    5
         Protocol deviation
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administration Within this double blind study the same procedure as described for Methylphenidat-HCl was applied for the placebo condition.

    Reporting group title
    Methylphenidate, non-retard
    Reporting group description
    		 Drug: Methylphenidate, non-retard Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg.

    Reporting group values
    		 Placebo Methylphenidate, non-retard Total
    Number of subjects
    		 16 19 35
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 16 19 35
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34 ( 9.78 ) 37.1 ( 9.72 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 9 16
        Male
    		 9 10 19

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administration Within this double blind study the same procedure as described for Methylphenidat-HCl was applied for the placebo condition.

    Reporting group title
    Methylphenidate, non-retard
    Reporting group description
    		 Drug: Methylphenidate, non-retard Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg.
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administration Within this double blind study the same procedure as described for Methylphenidat-HCl was applied for the placebo condition.

    Reporting group title
    Methylphenidate, non-retard
    Reporting group description
    		 Drug: Methylphenidate, non-retard Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg.

    Primary: Working memory task- 2Back misses

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    End point title
    		 Working memory task- 2Back misses
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 Placebo Methylphenidate, non-retard
    Number of subjects analysed
    13
    14
    Units: number of missed trials
        arithmetic mean (standard deviation)
    -6.41 ( 8.84 )
    -9.52 ( 11.27 )
    Statistical analysis title
    		 Change from pre to post treatment
    Statistical analysis description
    To test whether ADHS symptoms change over time differently in verum or placebo condition we reported the changes in scores from pre to post. The statistic approach was an ANOVA and we reported the p values of the interaction effect
    Comparison groups
    Placebo v Methylphenidate, non-retard
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.44
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Caars Inattentive

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    End point title
    		 Caars Inattentive
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks treatment
    End point values
    		 Placebo Methylphenidate, non-retard
    Number of subjects analysed
    13
    14
    Units: Questionaire score
        arithmetic mean (standard deviation)
    -8 ( 11.4 )
    -11.57 ( 6.97 )
    Statistical analysis title
    		 change from pre to post treatment
    Statistical analysis description
    To test whether ADHS symptoms change over time differently in verum or placebo condition we reported the changes in scores from pre to post. The statistic approach was an ANOVA and we reported the p values of the interaction effect
    Comparison groups
    Placebo v Methylphenidate, non-retard
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Variability estimate
    Standard deviation

    Secondary: Caars hyperactive/impulsive

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    End point title
    		 Caars hyperactive/impulsive
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks treatment
    End point values
    		 Placebo Methylphenidate, non-retard
    Number of subjects analysed
    13
    14
    Units: questionaire score
        arithmetic mean (standard deviation)
    -5.92 ( 6.84 )
    -6.14 ( 12.02 )
    Statistical analysis title
    		 changes in score from pre to post
    Statistical analysis description
    To test whether ADHS symptoms change over time differently in verum or placebo condition we reported the changes in scores from pre to post. The statistic approach was an ANOVA and we reported the p values of the interaction effect
    Comparison groups
    Placebo v Methylphenidate, non-retard
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.94
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs was collected from enrolment until the end of the study. The patients were seen every 2 weeks during treatment (4 visits within 6 weeks) and after 4 weeks at follow up.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Patients of verum group
    Reporting group description
    		 Patients of verum group who received at least one medication

    Reporting group title
    Patients of placebo group
    Reporting group description
    		 -

    Serious adverse events
    		 Patients of verum group Patients of placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Appendicitis
    Additional description: Occured after inclusion, but before beginning of actual study, in particular before medication
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Patients of verum group Patients of placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 19 (94.74%)
    10 / 16 (62.50%)
    Cardiac disorders
    Labile blood pressure
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Palpitations
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Therapeutic apical closure
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 19 (52.63%)
    4 / 16 (25.00%)
         occurrences all number
    12
    4
    Ear and labyrinth disorders
    Dizziness postural
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Sudden hearing loss
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
     Infection of gastrointestinal tract
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Acid reflux
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    diarrhea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    Stomach ache
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    menstrual problem
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
     Pain in throat 
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    cough
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Feeling agitated
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
      Difficulty sleeping
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    3
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 16 (18.75%)
         occurrences all number
    3
    4
    cramp
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    low back pain
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 16 (12.50%)
         occurrences all number
    3
    2
    Neck pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Tendinitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    rupture of meniscus of knee
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Infections and infestations
    common cold
         subjects affected / exposed
    6 / 19 (31.58%)
    1 / 16 (6.25%)
         occurrences all number
    8
    1
    Herpes zoster
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    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.
    We did not reach a sufficient number of patients based on the power calculation.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27207920
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