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    Clinical Trial Results:
    Pramipexole augmentation to target anhedonia in depression - a pilot study

    Summary
    EudraCT number
    		 2019-001907-19
    Trial protocol
    		 SE  
    Global end of trial date
    18 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2022
    First version publication date
    06 Jul 2022
    Other versions
    Summary report(s)
    		 Text appendix

    Trial information

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    Trial identification
    Sponsor protocol code
    PILOT-PRAXOL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04121091
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Swedish Ethical Review Authority: 2019-02843
    Sponsors
    Sponsor organisation name
    Region Skåne
    Sponsor organisation address
    Baravägen 1, Lund, Sweden, 22185
    Public contact
    Vuxenpsykiatri Lund, Region Skåne, daniel.lindqvist@med.lu.se
    Scientific contact
    Vuxenpsykiatri Lund, Region Skåne, 46 173885, daniel.lindqvist@med.lu.se
    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 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to test the efficacy of add-on pramipexole in treating anhedonia in patients with depression.
    Protection of trial subjects
    - Blood samples including eGFR, liver transaminases, hemoglobin and beta-hCG were taken before baseline visit to ensure treatment safety and exclude potential subject if pregnant. - All trial subjects were asked about history of cardiovascular or pulmonary disease. - All trial subjects were screened with Young Mania Rating Scale and Questionnaire for Impulsive-Compulsive Disorders (QUIP) at screening visit and every other week during participation. - All trial subjects were informed about the mechanisms of Pramipexole and the importance of adjusting the dosage in steps.
    Background therapy
    		 All trial subjects had a stable ongoing antidepressant medication at least four weeks prior to enrollment. Trial subjects with bipolar disorder also had stable medications with mood stabilizers.
    Evidence for comparator
    		 No comparators. All trial subjects received pramipexole.
    Actual start date of recruitment
    02 Sep 2019
    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
    Sweden: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first trial subject was enrolled 04-Nov-2019 and the last trial subject 05-Oct-2020. All patients were recruited from Scania, Sweden.

    Pre-assignment
    Screening details
    		 Test subjects with diagnosis of depression were recruited through self-referral and through referral from primary care and psychiatric clinics in Scania. If the test subject had an ongoing treatment with antipsychotics, a wash-out period of at least four weeks was applied (if it was assessed as appropriate by the test subjects doctor).

    Period 1
    Period 1 title
    Treatment with pramipexole baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment pramipexole baseline
    Arm description
    		 Treatment with pramipexole, baseline at week 0
    Arm type
    		 Baseline

    Investigational medicinal product name
    Pramipexole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pramipexole titrated to highest tolerable dose (doses in salt): Week 1: 1 tablet 0.375 mg Week 2: 1 tablet 0.75 mg Week 3: 1 tablet 1.5 mg Week 4: 1 tablet 1.5 mg + 1 tablet 0.75 mg (total dose: 2.25 mg) Week 5: 1 tablet 3 mg The increase in dosage was paused if the trial subject had limiting side effects or displayed at least 50% improvement regarding depressive symptoms.

    Number of subjects in period 1
    		Treatment pramipexole baseline
    Started
    12
    Completed
    12
    Period 2
    Period 2 title
    Treatment with pramipexole endpoint
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment with pramipexole endpoint
    Arm description
    		 After 10 weeks of treatment with pramipexole
    Arm type
    		 Endpoint

    Investigational medicinal product name
    Pramipexole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pramipexole titrated to highest tolerable dose (doses in salt): Week 1: 1 tablet 0.375 mg Week 2: 1 tablet 0.75 mg Week 3: 1 tablet 1.5 mg Week 4: 1 tablet 1.5 mg + 1 tablet 0.75 mg (total dose: 2.25 mg) Week 5: 1 tablet 3 mg The increase in dosage was paused if the trial subject had limiting side effects or displayed at least 50% improvement regarding depressive symptoms.

    Number of subjects in period 2
    		Treatment with pramipexole endpoint
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment with pramipexole baseline
    Reporting group description
    		 -

    Reporting group values
    		 Treatment with pramipexole baseline Total
    Number of subjects
    		 12 12
    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
        median (standard deviation)
    		 45.2 ± 15.7 -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 4 4
    SSRI users
    Users of selective serotonine reuptake inhibitors
    Units: Subjects
        Yes
    		 5 5
        No
    		 7 7
    SNRI users
    Users of serotonine norepinephrine reuptake inhibitors
    Units: Subjects
        Yes
    		 6 6
        No
    		 6 6
    NDRI users
    Users of norepinephrine dopamine reuptake inhibitors
    Units: Subjects
        Yes
    		 2 2
        No
    		 10 10
    Antipsychotic users
    Users of antipsychotics
    Units: Subjects
        Yes
    		 0 0
        No
    		 12 12
    Mood stabilizers users
    Users of mood stabilizers
    Units: Subjects
        Yes
    		 2 2
        No
    		 10 10
    Previously ECT
    Previously received electroconvulsive therapy
    Units: Subjects
        Yes
    		 4 4
        No
    		 8 8
    Anxiety comorbidity
    Anxiety disorder diagnosis
    Units: Subjects
        Yes
    		 6 6
        No
    		 6 6
    BMI
    Mean Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 30.2 ± 5.2 -
    CRP
    C-reactive peptide levels
    Units: ng/L
        arithmetic mean (standard deviation)
    		 3.8 ± 4.7 -
    Previous antidepressant treatment
    Median number of previous antidepressant treatments
    Units: treatments
        median (full range (min-max))
    		 5 (2 to 14) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment pramipexole baseline
    Reporting group description
    		 Treatment with pramipexole, baseline at week 0
    Reporting group title
    Treatment with pramipexole endpoint
    Reporting group description
    		 After 10 weeks of treatment with pramipexole

    Primary: Responder MADRS

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    End point title
    		 Responder MADRS
    End point description
    >50% decrease on MADRS
    End point type
    Primary
    End point timeframe
    Nov 2019 - Mar 2021
    End point values
    		 Treatment pramipexole baseline Treatment with pramipexole endpoint
    Number of subjects analysed
    12
    12
    Units: 12
        Yes
    4
    4
        No
    8
    8
    Attachments
    		 Untitled (Filename: Figure1A.png)
    Statistical analysis title
    		 Comparison of means
    Statistical analysis description
    Mean baseline value was compared to endpoint value using Wilcoxon signed ranks test. This was performed for MADRS, SHAPS and DARS, as well as CRP. See attached file for more information.
    Comparison groups
    Treatment pramipexole baseline v Treatment with pramipexole endpoint
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [1] - The mean values at baseline compared to the mean values at endpoint, in the (only) group - pramipexole treatment.

    Secondary: Responder SHAPS

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    End point title
    		 Responder SHAPS
    End point description
    >50% decrease on Snaith Hamilton Pleasure scale
    End point type
    Secondary
    End point timeframe
    Nov 2019 - Mar 2021
    End point values
    Number of subjects analysed
    Units: 12
        Yes
        No
    Attachments
    		 Untitled (Filename: Figure1A.png)
    No statistical analyses for this end point

    Other pre-specified: Endpoint pramipexole dose

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    End point title
    		 Endpoint pramipexole dose
    End point description
    Mean dose of pramipexole (mg salt/day) at week 10
    End point type
    Other pre-specified
    End point timeframe
    Nov 2019 - Mar 2021
    End point values
    Number of subjects analysed
    Units: mg salt/day
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Other pre-specified: Endpoint CRP

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    End point title
    		 Endpoint CRP
    End point description
    Mean level of hs-CRP (ng/L) at week 10
    End point type
    Other pre-specified
    End point timeframe
    Nov 2019 - Mar 2021
    End point values
    Number of subjects analysed
    Units: ng/L
        arithmetic mean (standard deviation)
    Attachments
    		 Untitled (Filename: Figure 2.png)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Nov 2019 - Mar 2021
    Adverse event reporting additional description
    Weekly report from trial subjects through a diary
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Treatment with pramipexole (all enrolled subjects)

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    10 / 12 (83.33%)
         occurrences all number
    10
    Nausea
         subjects affected / exposed
    9 / 12 (75.00%)
         occurrences all number
    9
    Fatigue
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Appetite disorder
    Additional description: Loss of appetite
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Eating disorder
    Additional description: Overeating, temporarily.
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Agitation
    Additional description: Mild agitation
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    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.
    This is a small pilot study, to examine the applicability of pramipexole in this patient group.
    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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