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    Clinical Trial Results:
    Prednisolone addition for atients with recent onset psychotic disorder: the role of immune-modulating strategies in the treatment of psychosis.

    Summary
    EudraCT number
    		 2014-000520-14
    Trial protocol
    		 NL   BE  
    Global end of trial date
    16 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2021
    First version publication date
    03 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NL46653
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02949232
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UMC Utrecht
    Sponsor organisation address
    Heidelberglaan 100, Utrecht, Netherlands,
    Public contact
    i.winter@umcutrecht.nl, University Medical Center Utrecht, i.winter@umcutrecht.nl
    Scientific contact
    i.winter@umcutrecht.nl, University Medical Center Utrecht, i.winter@umcutrecht.nl
    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
    16 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Different lines of evidence now suggest that low grade inflammation in the central lines of the central nervous system is involved in the pathogenesis of schizophrenia. Such inflammation could cause increased gray matter loss and consequently contribute to more severe negative and cognitive symptoms. We propose to investigate the effect of administering prednisolone (a broad-acting, potent immune suppressive agent) versus placebo, on psychotic symptoms, in addition to standard antipsychotic medication in patients with early stage schizophrenia or related disorders. This may revent neuronal damage caused by low-grade inflammatory rocesses in the brain. It is expected that symptom severity will be improved with prednisolone use.
    Protection of trial subjects
    Several events that may jeopardize the patient's health will prompt clinicians to end the study and start tapering the patient off the study medication immediately in line with the treatment guidelines for Inflammatory Bowel Diseases (2008) These events include the patient developing: - a blood glucose exceeding 7,0 mmol/L, In case a non-fasting glucose level was determined: a blood glucose level exceeding 11 mmol/L - suicidal ideations assessed by the CDSS, the following cut-off are applicable based on item 8: Suicidal ideations within the CDSS; Score of 0: no action (no suicidal ideation), Score of 1: consult with clinician (passive suicidal ideation), Score of 2/3: potential cause to stop study medication treatment – consult with clinician (active suicidal ideation). - the PANSS positive subscores which increase by 10 or more points without a clear reason (i.e. medication non-adherence) - the PANSS item G6 exceeding a score of 4 - the need for coercive treatment - pregnancy - oral systematic infectious disease. Laboratory assessments were conducted several times during this study. The lab results were checked by the study physician. Addiontally, each visit the adverse events and the concomitant medication were checked by the study physician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety, Scientific research
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 19
    Country: Number of subjects enrolled
    Belgium: 23
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    42
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited between 01 July 2014 and 01 February 2019. In total 246 potential candidates were approached for this study of which 68 patients signed informed consent and were screened for eligibility.

    Pre-assignment
    Screening details
    		 Eligible patients were aged 18-70, diagnosed with schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis NOS no longer than 7 years ago, treated with a stable dose of antipsychotic medication for at least three weeks and a minimum PANSS total score of 60. Patients were excluded when their BMI exceeded 30.

    Period 1
    Period 1 title
    Assignment and baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Randomization was performed centrally at the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. A web-based application was used and stratification was applied for sex. Blockrandomisation was performed for sexe and different centers and countries. . Trial treatment randomization codes were not available to the study staff.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Baseline: Prednisolone
    Arm description
    		 Prednisolone was initiated during the first week at 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks; in the second week, patients will use 25 mg/day, in the third week 20 mg/day is used etc. In the last week the patients will only take prednisolone on day 1-3 and day 5 and 7.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks.

    Arm title
    		 Baseline: Placebo
    Arm description
    		 Matching placebo 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks. After six weeks the placebo was completely discontinued.
    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
    40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks.

    Number of subjects in period 1
    		Baseline: Prednisolone Baseline: Placebo
    Started
    21
    21
    Completed
    21
    21
    Period 2
    Period 2 title
    End of treatment - 6 weeks treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 End of treatment: Prednisolone
    Arm description
    		 Prednisolone was initiated during the first week at 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks; in the second week, patients will use 25 mg/day, in the third week 20 mg/day is used etc. In the last week the patients will only take prednisolone on day 1-3 and day 5 and 7. At this visit, prednisolone was completely discontinued.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects will ingest the products in the form of identical tablets. In the current study, the following titration schedule will be employed (in line with the treatment guidelines for Inflammatory Bowel Diseases (2008)) which should minimize the occurrence of any side effects and withdrawal symptoms. 1. week 1: day 1-3: 40 mg/day, divided over two intakes; day 4-7: 30 mg/day, divided over two intakes 2. week 2: 25 mg/day, divided over two intakes 3. week 3: 20 mg/day, divided over two intakes 4. week 4: 15 mg/day, divided over two intakes 5. week 5: 10 mg/day, intake once daily 6. week 6: day 1-3: 5 mg/day, intake once daily; day 4-7: on day 5 and 7, 5 mg/day, intake once daily, on day 4 and 6 no tablets After week 6, prednisolone will be discontinued. These dosages are within the registered therapeutic dose range for prednisolone, which varies from 10 to 120mg/daily depending on disease severity.

    Arm title
    		 End of treatment : Placebo
    Arm description
    		 Participants will receive placebo capsules entirely matching prednisolone. At this visit the study medication was completely discontinued.
    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
    Subjects will ingest the products in the form of identical tablets. In the current study, the following titration schedule will be employed (in line with the treatment guidelines for Inflammatory Bowel Diseases (2008)) which should minimize the occurrence of any side effects and withdrawal symptoms. 1. week 1: day 1-3: 40 mg/day, divided over two intakes day 4-7: 30 mg/day, divided over two intakes 2. week 2: 25 mg/day, divided over two intakes 3. week 3: 20 mg/day, divided over two intakes 4. week 4: 15 mg/day, divided over two intakes 5. week 5: 10 mg/day, intake once daily 6. week 6: day 1-3: 5 mg/day, intake once daily day 4-7: on day 5 and 7, 5 mg/day, intake once daily, on day 4 and 6 no tablets.

    Number of subjects in period 2
    		End of treatment: Prednisolone End of treatment : Placebo
    Started
    21
    21
    Completed
    19
    20
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    -
    Period 3
    Period 3 title
    16-weeks follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prednisolone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the follow-up phase study medication was not used. However, patients, investigators, assessors and monitors were still blinded for the treatment arm.

    Arm title
    		 Placebo
    Arm description
    		 -
    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
    40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks. Study medication was already discontinued.

    Number of subjects in period 3
    		Prednisolone Placebo
    Started
    19
    20
    Completed
    9
    7
    Not completed
    10
    13
         Visit not conducted.
    8
    9
         Lost to follow-up
    2
    4
    Period 4
    Period 4 title
    26 weeks follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 26 weeks follow-up: Prednisolone
    Arm description
    		 Patients were not using prednisolone as this was discontinued at week 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks. Study medication was discontinued. Patients were not using study medication at this visit.

    Arm title
    		 26 weeks follow-up: Placebo
    Arm description
    		 Patients were not using placebo anymore, as study medication was discontinued at week 6.
    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
    40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks. Study medication was discontinued at this visit.

    Number of subjects in period 4
    		26 weeks follow-up: Prednisolone 26 weeks follow-up: Placebo
    Started
    9
    7
    Completed
    16
    10
    Not completed
    1
    6
         Patient missed visit
    1
    -
         Patients missed visit
    -
    5
         Lost to follow-up
    -
    1
    Joined
    8
    9
         Visit 16 was not conducted
    8
    9
    Period 5
    Period 5 title
    52 weeks follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 52 weeks follow-up: Prednisolone
    Arm description
    		 Prednisolone study medication was discontinued.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks. STudy medication was not used at this visit.

    Arm title
    		 52 weeks follow-up: placebo
    Arm description
    		 Placebo study medication was discontinued.
    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
    : 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks. Study medication was already discontinued.

    Number of subjects in period 5
    		52 weeks follow-up: Prednisolone 52 weeks follow-up: placebo
    Started
    16
    10
    Completed
    12
    13
    Not completed
    5
    2
         Lost to follow-up
    5
    2
    Joined
    1
    5
         Patient skipped 26 weeks visit
    1
    5

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Baseline: Prednisolone
    Reporting group description
    		 Prednisolone was initiated during the first week at 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks; in the second week, patients will use 25 mg/day, in the third week 20 mg/day is used etc. In the last week the patients will only take prednisolone on day 1-3 and day 5 and 7.

    Reporting group title
    Baseline: Placebo
    Reporting group description
    		 Matching placebo 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks. After six weeks the placebo was completely discontinued.

    Reporting group values
    		 Baseline: Prednisolone Baseline: Placebo Total
    Number of subjects
    		 21 21 42
    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)
    		 21 21 42
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.24 ± 10.60 28.0 ± 7.11 -
    Gender categorical
    Units: Subjects
        Female
    		 2 5 7
        Male
    		 19 16 35
    PANSS total
    Units: PANSS score
        arithmetic mean (standard deviation)
    		 81.23 ± 13.23 75.24 ± 10.54 -
    PANSS positive
    Units: PANSS score
        arithmetic mean (standard deviation)
    		 20.52 ± 5.48 17.95 ± 3.47 -
    PANSS negative
    Units: PANSS score
        arithmetic mean (standard deviation)
    		 20.90 ± 6.32 19.38 ± 4.49 -
    PANSS general
    Units: PANSS score
        arithmetic mean (standard deviation)
    		 39.81 ± 8.23 37.9 ± 7.46 -
    GAF score
    Units: GAF score
        arithmetic mean (standard deviation)
    		 41.57 ± 15.47 50.48 ± 16.38 -
    CDS score
    Units: CDS score
        arithmetic mean (standard deviation)
    		 5.38 ± 4.71 4.09 ± 3.52 -
    Subject analysis sets

    Subject analysis set title
    Intention to treat sample
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Of the patients who signed IC and passed the screening assessments, only those patients are included in the main analyses who have received the study medication.

    Subject analysis sets values
    		 Intention to treat sample
    Number of subjects
    42
    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)
    42
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    30.12 ± 9.168
    Gender categorical
    Units: Subjects
        Female
        Male
    PANSS total
    Units: PANSS score
        arithmetic mean (standard deviation)
    78.23 ± 12.25
    PANSS positive
    Units: PANSS score
        arithmetic mean (standard deviation)
    19.24 ± 4.72
    PANSS negative
    Units: PANSS score
        arithmetic mean (standard deviation)
    20.14 ± 5.47
    PANSS general
    Units: PANSS score
        arithmetic mean (standard deviation)
    38.86 ± 7.82
    GAF score
    Units: GAF score
        arithmetic mean (standard deviation)
    46.2 ± 16.7
    CDS score
    Units: CDS score
        arithmetic mean (standard deviation)
    4.74 ± 4.16

    End points

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    End points reporting groups
    Reporting group title
    Baseline: Prednisolone
    Reporting group description
    		 Prednisolone was initiated during the first week at 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks; in the second week, patients will use 25 mg/day, in the third week 20 mg/day is used etc. In the last week the patients will only take prednisolone on day 1-3 and day 5 and 7.

    Reporting group title
    Baseline: Placebo
    Reporting group description
    		 Matching placebo 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks. After six weeks the placebo was completely discontinued.
    Reporting group title
    End of treatment: Prednisolone
    Reporting group description
    		 Prednisolone was initiated during the first week at 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks; in the second week, patients will use 25 mg/day, in the third week 20 mg/day is used etc. In the last week the patients will only take prednisolone on day 1-3 and day 5 and 7. At this visit, prednisolone was completely discontinued.

    Reporting group title
    End of treatment : Placebo
    Reporting group description
    		 Participants will receive placebo capsules entirely matching prednisolone. At this visit the study medication was completely discontinued.
    Reporting group title
    Prednisolone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    26 weeks follow-up: Prednisolone
    Reporting group description
    		 Patients were not using prednisolone as this was discontinued at week 6.

    Reporting group title
    26 weeks follow-up: Placebo
    Reporting group description
    		 Patients were not using placebo anymore, as study medication was discontinued at week 6.
    Reporting group title
    52 weeks follow-up: Prednisolone
    Reporting group description
    		 Prednisolone study medication was discontinued.

    Reporting group title
    52 weeks follow-up: placebo
    Reporting group description
    		 Placebo study medication was discontinued.

    Subject analysis set title
    Intention to treat sample
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Of the patients who signed IC and passed the screening assessments, only those patients are included in the main analyses who have received the study medication.

    Primary: End of treatment

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    End point title
    		 End of treatment
    End point description
    End point type
    Primary
    End point timeframe
    The end of the six weeks treatment period.
    End point values
    		 End of treatment: Prednisolone End of treatment : Placebo
    Number of subjects analysed
    17
    19
    Units: PANSS total
        arithmetic mean (standard deviation)
    64.18 ± 16.51
    57.73 ± 10.16
    Statistical analysis title
    		 Treatment effect
    Statistical analysis description
    The analysis for the primary outcome was performed with a mixed model. Three nested mixed models were fitted to test the effects of the interaction between treatment and time (number of weeks after baseline) and of treatment as main effect respectively. These effects were tested using the Likelihood ratio test (LRT) by subtracting the −2 log Likelihoods from models with and without the relevant effect, which has a χ2 distribution. The modelsincluded time (categorical) and PANSS total baseline.
    Comparison groups
    End of treatment: Prednisolone v End of treatment : Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.96
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events and serious adverse events were reported until the end of the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Prednisolone
    Reporting group description
    		 Treatment of six weeks prednisolone

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Prednisolone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 21 (9.52%)
    5 / 21 (23.81%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Psychiatric disorders
    Psychotic exacerbation
         subjects affected / exposed
    2 / 21 (9.52%)
    5 / 21 (23.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug use disorder
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (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: 5%
    Non-serious adverse events
    		 Prednisolone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 21 (80.95%)
    17 / 21 (80.95%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Increased appetite
         subjects affected / exposed
    7 / 21 (33.33%)
    4 / 21 (19.05%)
         occurrences all number
    7
    4
    Fatigue
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 21 (4.76%)
         occurrences all number
    3
    1
    Decreased appetite
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Ankle edema
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    Eye disorders
    Spots before eyes
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Stomach ache
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 21 (4.76%)
         occurrences all number
    3
    1
    Vomiting
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 21 (9.52%)
         occurrences all number
    2
    2
    Abdominal discomfort
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    obstipation
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Heartburn
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    Dry mouth
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Saliva increased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Swelling face
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Dry skin
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Skin red
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 21 (9.52%)
         occurrences all number
    1
    2
    Skin lesion
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    Hirsutism
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Pimple
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Sweating
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depressive symptom
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 21 (4.76%)
         occurrences all number
    3
    1
    Mood altered
         subjects affected / exposed
    2 / 21 (9.52%)
    4 / 21 (19.05%)
         occurrences all number
    2
    4
    Insomnia
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 21 (9.52%)
         occurrences all number
    2
    2
    Aggression
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 21 (9.52%)
         occurrences all number
    1
    2
    Mood elevated
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Sleep excessive
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Suicidal ideation
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Tobacco abuse
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Euphoric mood
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Psychotic exacerbation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    Leg pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Cramp in hand
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Delayed healing of wound
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Muscle weakness
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    Pain in thumb
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Muscle stiffness
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Polydipsia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (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? Yes
    Date
    Amendment
    08 Jan 2016
    Change in eligibility criteria due to recruitment barrier o Inclusion criteria  CRP ≥3.9 was deleted as inclusion criterion  Duration of illness no longer than 5 years ago was changed into no longer than 7 years ago o Exclusion criteria  BMI >27.5 was changed into BMI >30.0
    19 Oct 2016
    - PBMC analysis was deleted from the study protocol as this analysis could not be performed by the majority of the participating centers. - Change in blood volume withdrawn for laboratory assessment - Change in Serious Adverse Event reporting were implemented; hospitalization due to psychiatric exacerbation is reported only in the annual line listings, due to the high frequency of occurrence at this stage of the illness and the fact that immediate reporting does not have added value. - Addition of a new participating center
    26 Jan 2017
    - Addition of extra visit; 16 weeks after baseline - Recruitment extension - Change in laboratory assessment
    15 May 2019
    - Reduction of participant sample and prematurely termination of the trial

    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
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