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    Clinical Trial Results:
    Pregabalin for anxiety comorbidity in patients with schizophrenia (PACS) - A Double-blinded Randomized Placebo Controlled Trial

    Summary
    EudraCT number
    		 2010-024488-42
    Trial protocol
    		 DK  
    Global end of trial date
    15 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2021
    First version publication date
    30 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2010-024488-42-PACS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01496690
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 The North Dk Region Comm. on Health Res. Ethics: N20100097
    Sponsors
    Sponsor organisation name
    Aalborg Psychiatric Hospital
    Sponsor organisation address
    Mølleparkvej 10, Aalborg, Denmark, 9000
    Public contact
    Centre for Psychosis Research, Aalborg University Hospital, Aalborg Psychiatric Hospital, 0045 29323543, ole.schjerning@rsyd.dk
    Scientific contact
    Centre for Psychosis Research, Aalborg University Hospital, Aalborg Psychiatric Hospital, 0045 29323543, ole.schjerning@rsyd.dk
    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
    01 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety.
    Protection of trial subjects
    All participants provided written informed consent to participation. This study was performed in accordance with the ICH-CGP guidelines and the Declaration of Helsinki. The Local Ethics Committee, the Danish Health Authority and the Danish Data Protection Agency approved the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 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
    Denmark: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    54
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from all five regions of Denmark. First patient was included at 5th of March 2012 and last patient ended the study at 15th of August 2016. The study was ended before sample size goal was met due to failure in accessing eligible patients.

    Pre-assignment
    Screening details
    		 Patients aged 18 to 65 years with a diagnosis of schizophrenia (ICD- 10: F20.0 to F20.3 or F20.9). No changes in primary psychopharmacologic treatment (antipsychotics, antidepressants and sedatives) for at least 4 weeks. Severity of anxiety was measured using the Hamilton Anxiety Scale. Patients with a total score above 15 were included.

    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, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Randomization was done in blocks with variable block size (4, 6 and 8) to maintain an equal allocation of patients over time. Randomization sequence was generated by the Hospital Pharmacy, Aalborg University Hospital, Aalborg, Denmark. All research staff and patientswere blinded to treatment allocation. Pregabalin capsules and placebo capsules were identical and provided by Pfizer Denmark.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pregabalin
    Arm description
    		 Active treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin/placebo was initiated at 75 mg/d. After one week, dosage was increased to 150 mg/d and a flexible dosage regiment allowing weekly increments by 150 mg/d, up to a maximum of 600 mg/d — depending on effect and tolerability. Dosages ≥450 mg/d were divided in two doses. Compliance was calculated after 4 and 8 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin/placebo was initiated at 75 mg/d. After one week, dosage was increased to 150 mg/d and a flexible dosage regiment allowing weekly increments by 150 mg/d, up to a maximum of 600 mg/d — depending on effect and tolerability. Dosages ≥450 mg/d were divided in two doses. Compliance was calculated after 4 and 8 weeks.

    Number of subjects in period 1
    		Pregabalin Placebo
    Started
    28
    26
    Completed
    22
    22
    Not completed
    6
    4
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    3
    2
         Compliance below 70%
    3
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Active treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Pregabalin Placebo Total
    Number of subjects
    		 28 26 54
    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)
    		 28 26 54
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 7 18
        Male
    		 17 19 36
    Subject analysis sets

    Subject analysis set title
    End trial analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Difference between ratings at baseline and after 8 weeks of treatment on the Hamilton Anxiety Scale.

    Subject analysis sets values
    		 End trial analysis
    Number of subjects
    54
    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)
        From 65-84 years
        85 years and over
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    18
        Male
    36

    End points

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    End points reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Active treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    End trial analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Difference between ratings at baseline and after 8 weeks of treatment on the Hamilton Anxiety Scale.

    Primary: HAM-A14

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    End point title
    		 HAM-A14
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks treatment
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    28
    26
    Units: HAM-A14 scale units
    28
    26
    Statistical analysis title
    		 Change in HAM-A14 score
    Statistical analysis description
    Difference between HAM-A14 ratings at baseline and after 8 weeks of treatment.
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 5.9
    Variability estimate
    Standard deviation

    Secondary: HAM-A6

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    End point title
    		 HAM-A6
    End point description
    End point type
    Secondary
    End point timeframe
    After 8 weeks treatment
    End point values
    		 Pregabalin Placebo
    Number of subjects analysed
    28
    26
    Units: HAM-A6 score
    28
    26
    Statistical analysis title
    		 Change in HAM-A6 scores
    Comparison groups
    Pregabalin v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 4
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    8 weeks of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Pregabalin
    Reporting group description
    		 Pregabalin/placebo was initiated at 75 mg/d. After one week, dosage was increased to 150 mg/d and a flexible dosage regiment allowing weekly increments by 150 mg/d, up to a maximum of 600 mg/d — depending on effect and tolerability. Dosages ≥450 mg/d were divided in two doses. Compliance was calculated after 4 and 8 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Pregabalin/placebowas initiated at 75 mg/d. After oneweek, dosage was increased to 150 mg/d and a flexible dosage regiment allowing weekly increments by 150 mg/d, up to a maximum of 600 mg/d — depending on effect and tolerability. Dosages ≥450 mg/d were divided in two doses. Compliance was calculated after 4 and 8 weeks.

    Serious adverse events
    		 Pregabalin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 26 (3.85%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Worsening of hallucinations
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
    Additional description: Suicide attempt using overdose of benzodiazepines
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pregabalin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 28 (100.00%)
    26 / 26 (100.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    5 / 28 (17.86%)
    4 / 26 (15.38%)
         occurrences all number
    5
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    11 / 28 (39.29%)
    5 / 26 (19.23%)
         occurrences all number
    11
    5
    Increased fatiguability
         subjects affected / exposed
    9 / 28 (32.14%)
    6 / 26 (23.08%)
         occurrences all number
    9
    6
    Sedation
         subjects affected / exposed
    5 / 28 (17.86%)
    4 / 26 (15.38%)
         occurrences all number
    5
    4
    Dystonia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Rigidity
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Hypokinesia
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Hyperkinesia
         subjects affected / exposed
    5 / 28 (17.86%)
    1 / 26 (3.85%)
         occurrences all number
    5
    1
    Tremor
         subjects affected / exposed
    3 / 28 (10.71%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Akathisia
         subjects affected / exposed
    7 / 28 (25.00%)
    3 / 26 (11.54%)
         occurrences all number
    7
    3
    Epileptic seizures
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Paresthesia
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 26 (7.69%)
         occurrences all number
    3
    2
    Dizziness postural
         subjects affected / exposed
    6 / 28 (21.43%)
    7 / 26 (26.92%)
         occurrences all number
    6
    7
    Headache
         subjects affected / exposed
    6 / 28 (21.43%)
    6 / 26 (23.08%)
         occurrences all number
    6
    6
    Eye disorders
    Accommodation disorder
         subjects affected / exposed
    5 / 28 (17.86%)
    1 / 26 (3.85%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Increased salivation
         subjects affected / exposed
    5 / 28 (17.86%)
    2 / 26 (7.69%)
         occurrences all number
    5
    2
    Dryness of mouth
         subjects affected / exposed
    4 / 28 (14.29%)
    5 / 26 (19.23%)
         occurrences all number
    4
    5
    Nausea
         subjects affected / exposed
    5 / 28 (17.86%)
    6 / 26 (23.08%)
         occurrences all number
    5
    6
    Diarrhoea
         subjects affected / exposed
    6 / 28 (21.43%)
    4 / 26 (15.38%)
         occurrences all number
    6
    4
    Constipation
         subjects affected / exposed
    3 / 28 (10.71%)
    3 / 26 (11.54%)
         occurrences all number
    3
    3
    Reproductive system and breast disorders
    Increased sexual desire
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Diminished sexual desire
         subjects affected / exposed
    6 / 28 (21.43%)
    2 / 26 (7.69%)
         occurrences all number
    6
    2
    Orgasmic dysfunction
         subjects affected / exposed
    7 / 28 (25.00%)
    3 / 26 (11.54%)
         occurrences all number
    7
    3
    Skin and subcutaneous tissue disorders
    Increased tendency to sweating
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    Rash
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    Pruritus
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 26 (3.85%)
         occurrences all number
    2
    1
    Photosensitivity reaction
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    Increased pigmentation
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 26 (0.00%)
         occurrences all number
    4
    0
    Psychiatric disorders
    Concentration difficulties
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 26 (11.54%)
         occurrences all number
    4
    3
    Failing memory
         subjects affected / exposed
    6 / 28 (21.43%)
    5 / 26 (19.23%)
         occurrences all number
    6
    5
    Depression
         subjects affected / exposed
    5 / 28 (17.86%)
    9 / 26 (34.62%)
         occurrences all number
    5
    9
    Tension
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 26 (15.38%)
         occurrences all number
    4
    4
    Increased duration of sleep
         subjects affected / exposed
    15 / 28 (53.57%)
    2 / 26 (7.69%)
         occurrences all number
    15
    2
    Reduced duration of sleep
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 26 (11.54%)
         occurrences all number
    2
    3
    Increased dream activity
         subjects affected / exposed
    6 / 28 (21.43%)
    3 / 26 (11.54%)
         occurrences all number
    6
    3
    Emotional indifference
         subjects affected / exposed
    4 / 28 (14.29%)
    2 / 26 (7.69%)
         occurrences all number
    4
    2
    Renal and urinary disorders
    Micturition disorder
         subjects affected / exposed
    5 / 28 (17.86%)
    4 / 26 (15.38%)
         occurrences all number
    5
    4
    Polyuria
         subjects affected / exposed
    9 / 28 (32.14%)
    2 / 26 (7.69%)
         occurrences all number
    9
    2
    Metabolism and nutrition disorders
    Weight gain poor
         subjects affected / exposed
    24 / 28 (85.71%)
    9 / 26 (34.62%)
         occurrences all number
    24
    9
    Weight loss
         subjects affected / exposed
    3 / 28 (10.71%)
    7 / 26 (26.92%)
         occurrences all number
    3
    7

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28919128
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