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    Clinical Trial Results:
    Effects of add-on Celecoxib treatment in patients with schizophrenia spectrum disorders and inflammatory cytokine profile (TargetFlame)

    Summary
    EudraCT number
    		 2021-002572-39
    Trial protocol
    		 DE  
    Global end of trial date
    07 Jan 2026

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Feb 2026
    First version publication date
    13 Feb 2026
    Other versions
    Summary report(s)
    		 CSR_TargetFlame 1.0

    Trial information

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    Trial identification
    Sponsor protocol code
    TargetFlame
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 PMID: 36401749, PMCID: PMC10374797, DOI: 10.1007/s00702-022-02566-6, DRKS : DRKS00029044
    Sponsors
    Sponsor organisation name
    Bezirkskliniken Schwaben
    Sponsor organisation address
    Geschwister-Schönert-Straße 4, München, Germany, 86156
    Public contact
    Dr. med. Christiane Blankenstein, TUM School of Medicine and Health Münchner Studienzentrum, 0049 8941406320, christiane.blankenstein@mri.tum.de
    Scientific contact
    Prof. Dr. med. Alkomiet Hasan, Bezirkskliniken Schwaben - vertreten durch Stefan Brunhuber, 0049 821 4803-1254, anja.baumgartner@bkh-augsburg.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
    04 Dec 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2026
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate improvements in psychopathology in patients with schizophrenia spectrum disorders having an inflammatory blood profile randomized to either Celecoxib or placebo
    Protection of trial subjects
    The safety, rights and well-being of subjects with schizophrenia are protected in accordance with the Declaration of Helsinki and ICH-GCP. Written informed consent is obtained prior to any trial-related procedures. The capacity to provide informed consent is assessed by qualified study physicians; involvement of a legally authorised representative is ensured where required by national law. Only clinically stable patients are included. Subjects with acute psychotic exacerbation or other conditions that may compromise safety or compliance are excluded. To minimise distress, study visits are aligned with routine psychiatric care whenever possible and conducted by trained staff experienced in the treatment of patients with severe mental disorders. The number and invasiveness of procedures are limited to the minimum necessary. Subjects are regulary monitored for psychiatric symptoms, suicidality and treatment-emergent adverse events. Any deterioration in mental status leads to immediate clinical evaluation and, if required, discontinuation of the investigational medicinal product and initiation of appropriate medical care. All adverse events are documented, assessed and reported according to regulatory requirements. A predefined risk management and emergency procedure is in place. Confidentiality is ensured through pseudonymisation and restricted access to data. Subjects may withdraw consent at any time without disadvantage for further medical care. The protocol and all subject-related documents were approved by an independent Ethics Committee prior to trial start.
    Background therapy
    		 Standard of care
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The multicentre, randomized, double-blind, placebo-controlled, parallel group clinical trial was conducted in Germany at two sites. Between July 2022 and Nov. 2024 all pro-inflammatory patients were randomised in one of the two arms. A randomization did not take place until a final check conforms that all inclusion or no exclusion criteria applied.

    Pre-assignment
    Screening details
    		 Pre-screening was conducted. Approximately 199 patients with schizophrenia spectrum disorders were planned for screening, including cytokine profiling and somatic exclusion. Patients with an inflamed profile (n=109 planned) are randomized to add-on Celecoxib or placebo. Screening (Day -21 to -1) followed written informed consent.

    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
    Blinding implementation details
    Study medication (Celecoxib or placebo) is identical in appearance and centrally labelled and dispensed by the pharmacy according to the randomization list. Treatment allocation is concealed from participants, investigators and study staff. Emergency unblinding is permitted only if medically required.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Inflamed Patients - Add-on Celecoxib
    Arm description
    		 Patients with schizophrenia spectrum disorders and a confirmed pro-inflammatory cytokine profile receive for 8 weeks (56 days) add-on Celecoxib in addition to standard antipsychotic treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Celecoxib
    Investigational medicinal product code
    SUB01143MIG
    Other name
    CAS number 169590-42-5,
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Celecoxib is administered orally at a total daily dose of 400 mg, given as 200 mg twice daily (morning and evening before meals) for 8 weeks (56 days).

    Arm title
    		 Inflamed Patients - Add-on Placebo
    Arm description
    		 Patients with schizophrenia spectrum disorders and a confirmed pro-inflammatory (“inflamed”) cytokine profile receive add-on placebo in addition to stable standard antipsychotic treatment. Placebo is administered orally twice daily (morning and evening before meals) for 8 weeks (56 days) in a schedule identical to Celecoxib.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo is administered orally twice daily (morning and evening before meals) for 8 weeks (56 days), following a schedule identical to the active treatment arm.

    Number of subjects in period 1
    		Inflamed Patients - Add-on Celecoxib Inflamed Patients - Add-on Placebo
    Started
    15
    15
    Completed
    12
    13
    Not completed
    3
    2
         incompliance to IMP intake
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Inflamed Patients - Add-on Celecoxib
    Reporting group description
    		 Patients with schizophrenia spectrum disorders and a confirmed pro-inflammatory cytokine profile receive for 8 weeks (56 days) add-on Celecoxib in addition to standard antipsychotic treatment.

    Reporting group title
    Inflamed Patients - Add-on Placebo
    Reporting group description
    		 Patients with schizophrenia spectrum disorders and a confirmed pro-inflammatory (“inflamed”) cytokine profile receive add-on placebo in addition to stable standard antipsychotic treatment. Placebo is administered orally twice daily (morning and evening before meals) for 8 weeks (56 days) in a schedule identical to Celecoxib.

    Reporting group values
    		 Inflamed Patients - Add-on Celecoxib Inflamed Patients - Add-on Placebo Total
    Number of subjects
    		 15 15 30
    Age categorical
    Age descriptes: range between 18 and 65 years
    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)
    		 15 15 30
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Freqencies of male and female patients - males = , females =
    Units: Subjects
        Female
    		 4 8 12
        Male
    		 11 7 18
    Sites
    Site frequencies (recruitment)
    Units: Subjects
        BKH Augsburg
    		 8 10 18
        LMU Munich
    		 7 5 12
    BMI
    Body-Mass-Index
    Units: BMI
        arithmetic mean (standard deviation)
    		 29.68 ( 4.06 ) 27.40 ( 4.64 ) -
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients who received at least one dose of IMP

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) population contains all patients in the ITT population except for those with major protocol violations and those who received per-protocol medication.

    Subject analysis sets values
    		 ITT PP
    Number of subjects
    30
    23
    Age categorical
    Age descriptes: range between 18 and 65 years
    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)
    30
    22
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Freqencies of male and female patients - males = , females =
    Units: Subjects
        Female
    12
    12
        Male
    18
    11
    Sites
    Site frequencies (recruitment)
    Units: Subjects
        BKH Augsburg
    18
    15
        LMU Munich
    12
    8
    BMI
    Body-Mass-Index
    Units: BMI
        arithmetic mean (standard deviation)
    28.55 ( 4.53 )
    28.49 ( 4.43 )

    End points

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    End points reporting groups
    Reporting group title
    Inflamed Patients - Add-on Celecoxib
    Reporting group description
    		 Patients with schizophrenia spectrum disorders and a confirmed pro-inflammatory cytokine profile receive for 8 weeks (56 days) add-on Celecoxib in addition to standard antipsychotic treatment.

    Reporting group title
    Inflamed Patients - Add-on Placebo
    Reporting group description
    		 Patients with schizophrenia spectrum disorders and a confirmed pro-inflammatory (“inflamed”) cytokine profile receive add-on placebo in addition to stable standard antipsychotic treatment. Placebo is administered orally twice daily (morning and evening before meals) for 8 weeks (56 days) in a schedule identical to Celecoxib.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients who received at least one dose of IMP

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) population contains all patients in the ITT population except for those with major protocol violations and those who received per-protocol medication.

    Primary: Change in symptom severity in randomized patients following treatment with add-on Celecoxib compared to control patients following treatment with add-on placebo as assessed by total PANSS score changes from baseline to two months (56 days) after treatment

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    End point title
    		 Change in symptom severity in randomized patients following treatment with add-on Celecoxib compared to control patients following treatment with add-on placebo as assessed by total PANSS score changes from baseline to two months (56 days) after treatment
    End point description
    Comparison of the mean change in total PANSS score from baseline to Day 56 between the add-on Celecoxib and add-on placebo groups in randomized patients with an inflamed profile.
    End point type
    Primary
    End point timeframe
    Baseline to Day 56 (8 weeks) after treatment initiation.
    End point values
    		 Inflamed Patients - Add-on Celecoxib Inflamed Patients - Add-on Placebo ITT PP
    Number of subjects analysed
    15
    15
    30
    23
    Units: Scores
    arithmetic mean (standard deviation)
        V1
    70.20 ( 14.23 )
    72.20 ( 10.83 )
    71.20 ( 12.47 )
    71.91 ( 11.64 )
        V3
    65.25 ( 19.54 )
    61.46 ( 7.61 )
    63.28 ( 14.41 )
    62.27 ( 13.99 )
    Statistical analysis title
    		 PANSS - primary endpoint
    Statistical analysis description
    comparison V1 vs V3 with wilcoxon test
    Comparison groups
    Inflamed Patients - Add-on Celecoxib v Inflamed Patients - Add-on Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.045 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [1] - Wilcoxon test V1 vs V3 for group 1 (celecoxib)
    [2] - Wilcoxon test V1 vs V3 for group 1 (celecoxib)
    Statistical analysis title
    		 Copy of PANSS - primary endpoint
    Statistical analysis description
    comparison V1 vs V3 with wilcoxon test
    Comparison groups
    Inflamed Patients - Add-on Placebo v Inflamed Patients - Add-on Celecoxib
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.003
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [3] - Wilcoxon test V1 vs V3 for group 2 (placebo)

    Secondary: PANSS Positive Score

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    End point title
    		 PANSS Positive Score
    End point description
    Comparison of the mean change in PANSS Positve Score from baseline to Day 56 between the add-on Celecoxib and add-on placebo groups in randomized patients with an inflamed profile.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 56 (8 weeks) after treatment initiation.
    End point values
    		 Inflamed Patients - Add-on Celecoxib Inflamed Patients - Add-on Placebo ITT PP
    Number of subjects analysed
    15
    15
    30
    23
    Units: Score
    arithmetic mean (standard deviation)
        V1
    17.80 ( 6.51 )
    16.13 ( 4.45 )
    16.97 ( 5.54 )
    16.65 ( 5.12 )
        V3
    15.17 ( 6.45 )
    13.62 ( 2.63 )
    14.36 ( 4.81 )
    14.05 ( 4.48 )
    No statistical analyses for this end point

    Secondary: PANSS Negative Score

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    End point title
    		 PANSS Negative Score
    End point description
    Change in PANSS Negative Score between V1 an V3
    End point type
    Secondary
    End point timeframe
    Baseline to Day 56 (8 weeks) after treatment initiation.
    End point values
    		 Inflamed Patients - Add-on Celecoxib Inflamed Patients - Add-on Placebo ITT PP
    Number of subjects analysed
    15
    15
    30
    23
    Units: Score
    arithmetic mean (standard deviation)
        V1
    17.60 ( 5.74 )
    19.80 ( 5.39 )
    18.70 ( 5.58 )
    19.43 ( 5.04 )
        V3
    17.17 ( 4.53 )
    15.46 ( 4.84 )
    16.28 ( 4.68 )
    16.23 ( 4.56 )
    No statistical analyses for this end point

    Secondary: Change in GAF-Scores

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    End point title
    		 Change in GAF-Scores
    End point description
    Change in function of the measure of GAF-Score.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 56 (8 weeks) after treatment initiation.
    End point values
    		 Inflamed Patients - Add-on Celecoxib Inflamed Patients - Add-on Placebo ITT PP
    Number of subjects analysed
    15
    15
    30
    23
    Units: Scores
    arithmetic mean (standard deviation)
        V1
    50.86 ( 7.65 )
    47.64 ( 10.99 )
    49.25 ( 9.43 )
    48.71 ( 10.35 )
        V3
    55.83 ( 11.36 )
    50.83 ( 8.82 )
    53.33 ( 10.27 )
    54.00 ( 9.80 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are assessed and recorded at each study visit from first administration of the investigational medicinal product until the end-of-treatment visit (Day 56 ±7 days).
    Adverse event reporting additional description
    Planned hospitalizations (pre-existing conditions or protocol-required procedures without serious deterioration), admissions for social reasons, and surgeries planned before trial entry are not considered SAEs. Re-hospitalization between V3 and V5 for psychiatric reasons is also not classified as an SAE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 The safety set consisted of all patients who entered the trial and was used for conducting all safety analyses.

    Serious adverse events
    		 Overall Study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Psychiatric disorders
    Schizoaffective disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 30 (53.33%)
    Investigations
    Weight increased
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Restlessness
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2023
    The following major changes were included in AM 1: The CSP was adapted due to further development of the algorithm for differentiation between inflamed/non-inflamed patients; change of investigator at trial site #2.
    11 Dec 2024
    The following major changes were included in AM 2: Deletion of follow-up visits (V4 and V5) post intervention.

    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/36401749
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