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    Summary
    EudraCT Number:2021-003850-21
    Sponsor's Protocol Code Number:InflaMed001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-06-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-003850-21
    A.3Full title of the trial
    Precision psychiatry: Anti-inflammatory medication in Immuno-metabolic depression
    Precieze psychiatrie: Anti-inflammatoire medicatie bij immune-metabole depressie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treating depression with anti-inflammatory drugs
    Behandeling van depressie met ontstekingsremmers
    A.3.2Name or abbreviated title of the trial where available
    InflaMed
    A.4.1Sponsor's protocol code numberInflaMed001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmsterdam UMC, location VUmc
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmsterdam UMC, location VUmc
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportHersenstichting
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, location VUmc
    B.5.2Functional name of contact pointDepartment of Psychiatry
    B.5.3 Address:
    B.5.3.1Street AddressOldenaller 1
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HJ
    B.5.3.4CountryNetherlands
    B.5.6E-mailf.lamers@amsterdamumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Celecoxib
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCelecoxib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immuno metabolic Depression
    Immuno metabole depressie
    E.1.1.1Medical condition in easily understood language
    Depression with imflammation and energy-related symptoms
    Depressie met onstekingen en energie-gerelateerde symptomen
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether a 12-week celecoxib treatment (400mg/day) added to treatment as usual (TAU, defined as pharmacotherapy and/or psychotherapy) is more effective in reducing depressive symptoms as measured with the Inventory of Depressive Symptomatology (IDS 30-item self-report version) than placebo in patients aged 18-65yr with major depressive disorder and IMD characteristics (atypical, energy-related symptoms (≥6 on IDS)(Lamers et al. 2020) and circulating CRP>1mg/L) during 12-week follow-up.
    E.2.2Secondary objectives of the trial
    To evaluate whether in patients aged 18-65yr with major depressive disorder and IMD characteristics (atypical, energy-related symptoms (≥6 on IDS) and circulating CRP>1mg/L) a 12-week adjunctive celecoxib treatment (400mg/day) vs placebo is:
    - more effective in reaching response (defined as 50% reduction in total IDS score) and remission (based on the Mini International Neuropsychiatric Interview [MINI])
    - more effective in improving functioning (WHO-DAS), lowering fatigue (CIS), food craving (GFCQ-T), and pain (Numeric Rating Scale)
    - more effective in lowering atypical-energy related symptoms (IDS atypical, energy-related symptom profile score)

    To better understand how and for whom celecoxib add-on treatment is effective, several biological makers are assessed:
    - inflammatory markers (CRP, IL-6, TNFa), cholesterol, triglycerides, glucose, BMI, waist circumference
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    ● Age 18-65 years
    ● DSM-5 diagnosis of MDD confirmed with clinical interview (MINI)
    ● Currently using pharmacotherapy (SSRI, SNRI, TCA, TetraCA, MAOI, other antidepressants [bupropion, vortioxetine, agomelatine]) and/or psychotherapy. Subjects should be on the current treatment for at least 4 weeks
    ● IDS score ≥26 and a score ≥6 on atypical, energy-related symptoms scale from IDS
    ● CRP>1mg/L
    ● A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
    o Is not a woman of child bearing potential (WOCBP)
    o Is a WOCBP and agrees to use, or is already using, a contraceptive method during the intervention period and up to 1 month after the intervention.
    ● signed informed consent
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • Contraindications for celecoxib (active peptic ulcers, gastrointestinal bleeding, impaired kidney function (creatinine clearance < 30 ml/min), impaired liver function (ALT > 2x upper limit of normal [ULT]), history of ischemic heart disease or stroke, heart failure, allergic reactions to aspirin/NSAIDs/coxibs, use of anticoagulants
    • ECT in the past 3 months
    • Being on other psychotropic drugs
    • Clinically overt alcohol/drug dependence or other primary psychiatric diagnoses (schizophrenia, schizoaffective, OCD, or bipolar disorder)
    • Chronic use of anti-inflammatory drugs and corticosteroids
    • Not speaking Dutch
    E.5 End points
    E.5.1Primary end point(s)
    The main study outcome is the change in Inventory of Depressive Symptomatology (IDS, 30-item self-report) total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2, 4, 6, 8 ,10 and 12 weeks after the start of the intervention
    E.5.2Secondary end point(s)
    ● Response (50% reduction in IDS scores)
    ● Remission: MINI-S diagnostic interview
    ● Adverse side effects (PREDDICT and ASEC-21 questionnaire)
    ● Symptom profiles (atypical, energy-related;) based on IDS
    ● Fatigue (Checklist Individuele Spankracht)
    ● Food craving (General Food Craving Questionnaire Trait [GFCQ-T])
    ● Sleep (Epsworth Sleepiness Scale [ESS] and sleep duration from the PSQI)
    ● Anxiety symptoms (GAD-7)
    ● Functioning (WHO-Das)
    ● Pain (Numeric Rating Scale)
    ● Therapy compliance (pill count at 12 wk)
    ● Change in blood levels of CRP, IL-6, TNF-α, cholesterol, triglycerides, glucose
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 week after the start of the intervention
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-02
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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