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    Clinical Trial Results:
    Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram

    Summary
    EudraCT number
    		 2007-004009-93
    Trial protocol
    		 IT  
    Global end of trial date
    23 Jul 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2017
    First version publication date
    05 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    12118A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lundbeck Italy
    Sponsor organisation address
    Via della Moscova 3, Milano , Italy, 20121
    Public contact
    LundbeckClinicalTrials@lundbeck.com, LUNDBECK ITALIA SpA, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, LUNDBECK ITALIA SpA, LundbeckClinicalTrials@lundbeck.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
    23 Jul 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jul 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2010
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the present study is to evaluate the efficacy and safety of escitalopram 10-20 mg/day in depression, anxiety or impulse control disorder (ICD) symptoms in patients suffering from Parkinson disease (efficacy objective)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Nov 2008
    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
    Italy: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    8
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Parkinson patients with depression symptoms
    Arm description
    		 Study duration per patient was 6 months as per treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Escitalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose: 5 mg/day for 1 week. Dose adjustment was allowed starting from the first visit (1.5 month after treatment start) with possible increase up to 20 mg/day according to clinical needs. Flexible doses 10-20 mg/day were allowed from visit 1 to the end of treatment.

    Arm title
    		 Parkinson patients with anxiety symptoms
    Arm description
    		 Study duration per patient was 6 months as per treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Escitalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose: 5 mg/day for 1 week. Dose adjustment was allowed starting from the first visit (1.5 month after treatment start) with possible increase up to 20 mg/day according to clinical needs. Flexible doses 10-20 mg/day were allowed from visit 1 to the end of treatment.

    Arm title
    		 Parkinson patients with impulse control symptoms
    Arm description
    		 Study duration per patient was 6 months as per treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Escitalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose: 5 mg/day for 1 week. Dose adjustment was allowed starting from the first visit (1.5 month after treatment start) with possible increase up to 20 mg/day according to clinical needs. Flexible doses 10-20 mg/day were allowed from visit 1 to the end of treatment.

    Number of subjects in period 1
    		Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control symptoms
    Started
    2
    2
    10
    Completed
    0
    2
    5
    Not completed
    2
    0
    5
         Adverse event, non-fatal
    1
    -
    3
         Lost to follow-up
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 14 14
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.1 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 9 9
    Race
    Units: Subjects
        Caucasian
    		 14 14
    Subject analysis sets

    Subject analysis set title
    Parkinson patients with depression symptoms
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Depression symptoms in patients suffering from Parkinson disease

    Subject analysis set title
    Parkinson patients with anxiety symptoms
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anxiety symptoms in patients suffering from Parkinson disease

    Subject analysis set title
    Parkinson patients with impulse control disorder symptoms
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    impulse control disorder (ICD) symptoms in patients suffering from Parkinson disease

    Subject analysis sets values
    		 Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects
    2
    2
    10
    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)
    1
    0
    7
        From 65-84 years
    1
    2
    3
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    66.5 ( 9.2 )
    71 ( 7.1 )
    59.4 ( 6.9 )
    Gender categorical
    Units: Subjects
        Female
    1
    2
    2
        Male
    1
    0
    8
    Race
    Units: Subjects
        Caucasian
    2
    2
    10

    End points

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    End points reporting groups
    Reporting group title
    Parkinson patients with depression symptoms
    Reporting group description
    		 Study duration per patient was 6 months as per treatment period.

    Reporting group title
    Parkinson patients with anxiety symptoms
    Reporting group description
    		 Study duration per patient was 6 months as per treatment period.

    Reporting group title
    Parkinson patients with impulse control symptoms
    Reporting group description
    		 Study duration per patient was 6 months as per treatment period.

    Subject analysis set title
    Parkinson patients with depression symptoms
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Depression symptoms in patients suffering from Parkinson disease

    Subject analysis set title
    Parkinson patients with anxiety symptoms
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Anxiety symptoms in patients suffering from Parkinson disease

    Subject analysis set title
    Parkinson patients with impulse control disorder symptoms
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    impulse control disorder (ICD) symptoms in patients suffering from Parkinson disease

    Primary: Change from baseline in Hamilton Rating Scale for Depression (HAM-D) score

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    End point title
    		 Change from baseline in Hamilton Rating Scale for Depression (HAM-D) score [1]
    End point description
    End point type
    Primary
    End point timeframe
    baseline to end 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: Descriptive statistics
    End point values
    		 Parkinson patients with depression symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    2
    4
    Units: Score
        arithmetic mean (standard deviation)
    -2.5 ( 3.5 )
    2 ( 6 )
    No statistical analyses for this end point

    Primary: Change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) score

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    End point title
    		 Change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) score [2]
    End point description
    End point type
    Primary
    End point timeframe
    baseline to end of treatment
    Notes
    [2] - 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: Descriptive statistics
    End point values
    		 Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    2
    5
    Units: score
        arithmetic mean (standard deviation)
    -8 ( 5.7 )
    -1.4 ( 7.1 )
    No statistical analyses for this end point

    Primary: Change from baseline in Barrat Impulsivness Scale (BIS) total score

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    End point title
    		 Change from baseline in Barrat Impulsivness Scale (BIS) total score [3]
    End point description
    End point type
    Primary
    End point timeframe
    baseline to end of treatment
    Notes
    [3] - 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: Descriptive statistics
    End point values
    		 Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    2
    2
    7
    Units: Score
        arithmetic mean (standard deviation)
    18 ( 41 )
    2.5 ( 20.5 )
    5.6 ( 14 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Unified Parkinson Disease Rating Scale (UPDRS) total score

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    End point title
    		 Change from baseline in Unified Parkinson Disease Rating Scale (UPDRS) total score
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to end of treatment
    End point values
    		 Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    2
    2
    7
    Units: Scale
        arithmetic mean (standard deviation)
    5 ( 7.1 )
    -8.5 ( 12 )
    -0.3 ( 3.8 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Visual Analogic Scale (VAS) for daily off time.

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    End point title
    		 Change from baseline in Visual Analogic Scale (VAS) for daily off time.
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment
    End point values
    		 Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    1
    2
    7
    Units: Scale
        arithmetic mean (standard deviation)
    9 ( 0 )
    -0.2 ( 0.2 )
    -0.6 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Change from baseline in UPDRS-II (ADL)

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    End point title
    		 Change from baseline in UPDRS-II (ADL)
    End point description
    Unified Parkinson Disease Rating Scale (UPDRS)
    End point type
    Secondary
    End point timeframe
    baseline to end of treatment
    End point values
    		 Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    2
    2
    7
    Units: Scores
        arithmetic mean (standard deviation)
    2.5 ( 3.5 )
    -1.5 ( 3.5 )
    -1.1 ( 3.1 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)

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    End point title
    		 Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to end of treatment
    End point values
    		 Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    2
    2
    7
    Units: Score
        arithmetic mean (standard deviation)
    25 ( 17 )
    -26.5 ( 12 )
    -12 ( 14.6 )
    No statistical analyses for this end point

    Secondary: Change from baseline in BDI; depression self evaluation

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    End point title
    		 Change from baseline in BDI; depression self evaluation
    End point description
    Beck Depression Inventory (BDI); depression self evaluation
    End point type
    Secondary
    End point timeframe
    baseline to end of treatment
    End point values
    		 Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    2
    2
    7
    Units: Score
        arithmetic mean (standard deviation)
    3 ( 11.3 )
    -3 ( 9.9 )
    -2.1 ( 2.9 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Symptom Check List-90 (SCL-90) compulsive behaviour – self evaluation

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    End point title
    		 Change from baseline in Symptom Check List-90 (SCL-90) compulsive behaviour – self evaluation
    End point description
    Symptom Check List-90 (SCL-90); compulsive behavior – self evaluation
    End point type
    Secondary
    End point timeframe
    baseline to end of treatment
    End point values
    		 Parkinson patients with depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Number of subjects analysed
    2
    2
    7
    Units: Score
        arithmetic mean (standard deviation)
    51 ( 17 )
    -61 ( 8.5 )
    -16.7 ( 30.7 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Parkinson patients witn depression symptoms
    Reporting group description
    		 -

    Reporting group title
    Parkinson patients with anxiety symptoms
    Reporting group description
    		 -

    Reporting group title
    Parkinson patients with impulse control disorder symptoms
    Reporting group description
    		 -

    Serious adverse events
    		 Parkinson patients witn depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    severe pericarditis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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
    		 Parkinson patients witn depression symptoms Parkinson patients with anxiety symptoms Parkinson patients with impulse control disorder symptoms
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    4 / 10 (40.00%)
    Nervous system disorders
    On and Off phenomenon
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Anxiety aggravated
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Sep 2007
    -New title -The Padua Inventory (PI) was been replaced by the Barrat Impulsiveness Scale (BIS) as primary efficacy parameter for ICD diagnostic group - The PI has been replaced by BIS in the following paragraphes of the protocol -The MINI structured interview has been introduced for diagnosis to be made

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Jul 2010
    it was decided to stop enrolment for this study, because of enrolment difficulties at site. Planned sample size was more than 200 patients
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated and no meaningful interpretations can be made. Planned sample size was more than 200 patients
    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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