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    Summary
    EudraCT Number:2015-003413-26
    Sponsor's Protocol Code Number:MINDEP
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-003413-26
    A.3Full title of the trial
    Understanding the molecular basis for the use of adjunctive anti-inflammatory treatment in treatment resistant depression: a stratified, randomised, placebo-controlled, experimental medicine study using minocycline.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Minocycline and Depression (MINDEP) study
    A.3.2Name or abbreviated title of the trial where available
    Minocycline and Depression (MINDEP) study
    A.4.1Sponsor's protocol code numberMINDEP
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR BRC
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Valeria Mondelli
    B.5.3 Address:
    B.5.3.1Street AddressIoPPN, The Maurice Wohl Clinical Neuroscience Institute, Cutcombe Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44(0)207848 0353
    B.5.6E-mailvaleria.mondelli@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR BRC
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSouth London and Maudsley NHS Foundation Trust
    B.5.2Functional name of contact pointDr Valeria Mondelli
    B.5.3 Address:
    B.5.3.1Street AddressIoPPN, The Maurice Wohl Clinical Neuroscience Institute, Cutcombe Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44(0)207848 0353
    B.5.6E-mailvaleria.mondelli@kcl.ac.uk
    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 Acnamino MR 100mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderDexcel®-Pharma Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNminocycline hydrochloride
    D.3.9.1CAS number 13614-98-7
    D.3.9.3Other descriptive nameMinocycline
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Depression
    E.1.1.1Medical condition in easily understood language
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim is to investigate association between changes in inflammatory biomarkers and improvement in depressive symptoms following adjunctive treatment with minocycline in treatment resistant depressed patients selected for increased inflammation.
    E.2.2Secondary objectives of the trial
    The secondary aim is to identify molecular inflammatory pathways involved in the response to anti-inflammatory treatment in the same patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be aged 25-60
    2. Have a current DSM-IV diagnosis of nonpsychotic major depressive disorder, confirmed by the Mini International Neuropsychiatric Interview (MINI);
    3. Be non-responders to the current antidepressant taken at therapeutic doses for at least 6 weeks, as indicated by a current score of at least 14 on the 17-item Hamilton Depression Rating Scale (HAMD);
    4. Be tolerant to the current antidepressant, and accepting augmentation with minocycline;
    5. Have CRP levels ≥ 1 mg/L, indicative of mild-moderate inflammation;
    6. Have the ability to understand and sign a written informed consent form prior to participation in any screening procedures and a willingness to comply with all trial requirements.
    E.4Principal exclusion criteria
    1. have active suicidal ideation of significant concern to require intensive monitoring by secondary psychiatry services;
    2. have a primary diagnosis of bipolar disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or substance/alcohol misuse disorder;
    3. are taking warfarin;
    4. have received tetracycline within the previous 2 months, or have a history of sensitivity or intolerance to this class of drugs;
    5. have an acute infection; or have an autoimmune or inflammatory disorder, because of both the rare but described association between minocycline and systemic lupus erythematosus, and the potential confounder effects of these conditions on immune biomarkers.
    6. have hepatic or renal failure
    7. take any other psychotropic medications other than their current antidepressant that has not been approved by a study investigator prior to enrolment
    8. Refuse that we contact their General Practitioner (GP) to inform them about their participation in the study.
    9. (Females) Have a positive pregnancy test before starting the study/are unwilling to take a pregnancy test and are unwilling to agree to use an acceptable form of contraceptive throughout the study period (e.g. condoms, IUD/IUS, injection, patch, ring). Female participants who use combined oral contraceptives as their main form of birth control will need to use an additional barrier method for the duration of treatment and for 7 days following completion of treatment.
    10. Breastfeeding (females)
    11. Are currently participating in a clinical trial of an investigational medical product (CTIMP). For individuals who have been recently on CTIMP clinical trials, we will decide on case by case basis if they could be included in the trial according to the type of trial they have been involved in.
    E.5 End points
    E.5.1Primary end point(s)
    Changes from baseline to Week 4 for Hamilton Depression Rating Scale total score, including the percentage of patients who show response, defined as 50% reduction in the baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Changes in depression scores will be evaluated at the end of the 4 weeks of treatment with either minocycline or placebo.
    E.5.2Secondary end point(s)
    Clinical outcome: Changes from baseline to week 4 for Beck Depression Inventory, State and Trait Anxiety Inventory and Clinical Global Impression scale.

    Biological outcome: Changes from baseline to Week 4 in cytokines and kynurenine pathway metabolites and transcriptomics.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The changes in clinical symptoms and biological measurements will be evaluated at the end of the 4 weeks of treatment with either minocycline or placebo.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    The trial will end when all patients have had their final visits, and all data is entered into the database, and all queries resolved and the database is locked.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state44
    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)
    As this is a small pilot study, and the outcome is unknown, there are no arrangements made for continued provision of intervention. At the end of the trial, participants will have access to their healthcare services as usual.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-17
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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