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    Clinical Trial Results:
    Randomized double-blind, placebo controlled study with NEURAPAS® balance in addition to psychoeducation or psychotherapy in adolescents from 12 to 17 years suffering from mild depressive episodes with nervous restlessness

    Summary
    EudraCT number
    		 2012-004627-20
    Trial protocol
    		 DE  
    Global end of trial date
    10 Feb 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Feb 2016
    First version publication date
    23 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Acc. to the update of the EUDRACT-DB by EMA a review of the results has to be made. We will try to correct some data mistakes which occured due to prior failures in the EucraCT-DB.

    Trial information

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    Trial identification
    Sponsor protocol code
    176S11NB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PASCOE pharmazeutische Präparate GmbH
    Sponsor organisation address
    Schiffenberger Weg 55, Giessen, Germany, 35394
    Public contact
    Project manager, PASCOE pharmazeutische Präparate GmbH, 0049 641-7960-963, bianka.krick@gmx.de
    Scientific contact
    Project manager, PASCOE pharmazeutische Präparate GmbH, 0049 641-7960-963, bianka.krick@gmx.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
    27 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective was to prove superiority of NEURAPAS® balance (pooled data of both dosages) compared to placebo in improving depressive symptoms, measured by means of the German version of the CDRS-R (Children's Depression Rating Scale, Revised) after 6 weeks treatment
    Protection of trial subjects
    The only measure in this trial with a potential risk for the participants was blood sampling, where e.g. pain, bruises, hematoma, injury of nerves or infections may occur. No adverse events due to the blood sampling occured. Further risks due to the trial design or trial measures were not expected. Study was terminated on 10th Feb 2014 due to insufficient patient recruitment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2013
    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: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    4
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Germany: July 13 - Feb 14: 5 pat were enrolled: 1 pat was screening failure, 4 pat were randomized (1x verum 3x1, 2x verum 3x2 and 1x placebo): 2 of these pat were drop outs (due to "pat's wish" and "pat developed suicidal ideations").

    Pre-assignment
    Screening details
    		 Germany: July13-Feb14: 5 pat were enrolled: 1 pat was scr. fail., 4 pat were rand: 2 of these pat were drop outs. Due to an error of the database, it is not possible to enter correct number of enrolled pat (acc. Email 30/04/15 and 02/02/16 'The system cannot differentiate between treated and enrolled.' ). Complete data for 2 pat are assessable.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 3x2 verum
    Arm description
    		 patient received 3x2 tbl a day verum
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neurapas balance
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    NEURAPAS® balance 3 x 2 film-coated tablets daily Each film-coated tablet contains • 60 mg dry extract from St John's Wort Herb (Hypericum perforatum L.), drug-extract ratio 4.6- 6.5:1, extraction solvent ethanol 38 % m/m; • 28 mg dry extract from Valerian Root (Valeriana officinalis L.), drug-extract ratio 3.8-5.6:1, extraction solvent ethanol 40 % m/m; and • 32 mg dry extract ) from Passion Flower Herb (Passiflora incarnata L.), drug-extract ratio 6.25- 7.1:1, extraction solvent ethanol 60 % m/m.

    Arm title
    		 3x1 verum
    Arm description
    		 patients received 3x1 tbl a day verum and 3x1 tbl a day placebo
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neurapas balance
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    NEURAPAS® balance 3 x 1 film-coated tablets daily + Placebo, 3 x 1 film-coated tablets daily Verum contains: • 60 mg dry extract from St John's Wort Herb (Hypericum perforatum L.), drug-extract ratio 4.6- 6.5:1, extraction solvent ethanol 38 % m/m; • 28 mg dry extract from Valerian Root (Valeriana officinalis L.), drug-extract ratio 3.8-5.6:1, extraction solvent ethanol 40 % m/m; and • 32 mg dry extract ) from Passion Flower Herb (Passiflora incarnata L.), drug-extract ratio 6.25- 7.1:1, extraction solvent ethanol 60 % m/m.

    Arm title
    		 Placebo
    Arm description
    		 patients received 3x2 tbl a day placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, 3 x 2 film-coated tablets daily Pharmacologic active ingredients: None Other ingredients: Lactose 1H2O, talcum, magnesium stearate, alkaline butyl methacrylate copolymer (Eudragit E), macrogol 6000, titanium dioxide (E 171), indigocarmine (E 132).

    Number of subjects in period 1
    		3x2 verum 3x1 verum Placebo
    Started
    2
    1
    1
    Completed
    0
    1
    1
    Not completed
    2
    0
    0
         Consent withdrawn by subject
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    3x2 verum
    Reporting group description
    		 patient received 3x2 tbl a day verum

    Reporting group title
    3x1 verum
    Reporting group description
    		 patients received 3x1 tbl a day verum and 3x1 tbl a day placebo

    Reporting group title
    Placebo
    Reporting group description
    		 patients received 3x2 tbl a day placebo

    Reporting group values
    		 3x2 verum 3x1 verum Placebo Total
    Number of subjects
    		 2 1 1 4
    Age categorical
    age of patients in years
    Units: Subjects
        Adolescents (12-17 years)
    		 2 1 1 4
    Age continuous
    age of patients in years (mean value)
    Units: years
        arithmetic mean (full range (min-max))
    		 16 (16 to 16) 17 (17 to 17) 13 (13 to 13) -
    Gender categorical
    gender of the patients
    Units: Subjects
        Female
    		 2 1 1 4
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    3x2 verum
    Reporting group description
    		 patient received 3x2 tbl a day verum

    Reporting group title
    3x1 verum
    Reporting group description
    		 patients received 3x1 tbl a day verum and 3x1 tbl a day placebo

    Reporting group title
    Placebo
    Reporting group description
    		 patients received 3x2 tbl a day placebo

    Primary: Change from baseline of CDRS-R at week 6

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    End point title
    		 Change from baseline of CDRS-R at week 6 [1]
    End point description
    Note: Due to insufficient enrollment only safety-relevant data were evaluated. There were only data of 5 enrolled patients. Of these, one patient was a screening failure and two patients were drop outs. So there were complete data for 2 patients only. Therefore, the originally planned evaluation of the efficacy data has had to be abandoned.
    End point type
    Primary
    End point timeframe
    from baseline of CDRS-R at week 6
    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: Due to insufficient enrollment only safety-relevant data were evaluated. There were only data of 5 enrolled patients. Of these, one patient was a screening failure and two patients were drop outs. So there were complete data for 2 patients only. Therefore, the originally planned evaluation of the efficacy data has had to be abandoned.
    End point values
    Number of subjects analysed
    Units: score points
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs should be recorded from the time the subject provides informed consent to the last visit. Each SAE is followed up until complete recovery or the reasons for AE are identified, but the follow up ends 4 weeks after termination of study at latest.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    3x2 verum
    Reporting group description
    		 patient received 3x2 tbl a day verum

    Reporting group title
    placebo
    Reporting group description
    		 patients received 3x2 tbl a day placebo

    Reporting group title
    3x1 verum
    Reporting group description
    		 patients received 3x1 tbl a day verum and 3x1 tbl a day placebo

    Serious adverse events
    		 3x2 verum placebo 3x1 verum
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 3x2 verum placebo 3x1 verum
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    Nervous system disorders
    recurrent headache
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    increased appetite
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    suicidal ideations
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2013
    The amendments to the documents (protocol and IB) resulting from claims by leading ethics commission (ffEK).

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Feb 2014
    The clinical examination had to be canceled due to insufficient recruitment to 10/02/2014.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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