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    Summary
    EudraCT Number:2020-002787-32
    Sponsor's Protocol Code Number:RG_19-172
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-16
    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 number2020-002787-32
    A.3Full title of the trial
    Antidepressant for the prevention of DEPression following first episode Psychosis trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antidepressant for the prevention of DEPression following first episode Psychosis trial
    A.3.2Name or abbreviated title of the trial where available
    ADEPP
    A.4.1Sponsor's protocol code numberRG_19-172
    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 SponsorUniversity of Birmingham
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointBirmingham Clinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressPublic Health Building
    B.5.3.2Town/ cityEdgbaston
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailADEPP@trials.bham.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.2.1.2Country 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.3.1Product nameSertraline
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNsertraline hydrochloride
    D.3.9.1CAS number 79559-97-0
    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 number50
    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 placeboTablet
    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
    Patients with First Episode Psychosis.
    E.1.1.1Medical condition in easily understood language
    Patients who are experience symptoms of psychosis for the first time.
    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
    The main trial's primary objective is to assess the effectiveness and cost effectiveness of an antidepressant medication (sertraline) for the prevention of a depressive episode following first episode psychosis.

    The primary outcome will be the number of new cases of depression as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of greater than 5 and confirmed by Mini International Neuropsychiatric Interview (MINI) in each treatment arm over the 6-month intervention phase.

    A feasibility pilot study is incorporated into this study to assess acceptability of the trial 12 months into recruitment, using clear traffic light stop-go criteria. The percentage of eligible patients recruited, percentage of usable data of the first 50 recruits, retention rate and adherence rate will be assessed.
    E.2.2Secondary objectives of the trial
    Secondary Outcomes:
    1. Assess the presence and change in symptoms of psychosis using the Positive and Negative Syndrome Scale (PANSS; the established 30 item semi-structured interview). It has both total score and subscales for positive, negative and general symptoms.

    2. Assess the presence of suicidal ideation and attempts in lifetime ever and preceding 12 months, together with current suicidal ideation and beliefs about future risk, using the Suicidal Behaviours Questionnaire-Revised (SBQ-R; a 4 item validated tool). It has established linear total and cut off scores to identify those with and without the reported risk.

    3. Assess trait and current (state) anxiety using the State-Trait Anxiety Inventory (STAI; commonly used 20 item self-report scale).

    4. Assess generalised anxiety using the General Anxiety Disorder (GAD7; a brief 7 item anxiety scale).

    5. Relapse of psychosis: as defined by a hospital admission or acute community care provided by Home Treatment / Crisis Interventi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of first-episode psychosis (FEP).
    • Within 3 months of initial treatment for FEP (as defined by onset of care provision by an Early Intervention Team).
    • Positive and Negative Syndrome Scale (PANSS) individual positive item scores all ≤ 4.
    • Sufficiently recovered from acute psychotic episode with capacity to consent.
    • Aged 18-35 years.
    • Currently prescribed antipsychotic medication at stable dose.
    E.4Principal exclusion criteria
    • Current moderate or severe depression (as indicated by a Calgary Depression for
    Schizophrenia Scale (CDSS) score of >7).
    • Currently prescribed antidepressant medication (or within 2 weeks of stopping if a Monoamine Oxidaise Inhibitor)
    • Previous history of mania.
    • Contraindications to selective serotonin reuptake inhibitors (SSRI) antidepressant treatment (e.g. recurrent thrombotic illness, previous adverse reaction, confirmed pregnancy, although risk in pregnancy is low, prescribed pimozide).
    • Serious medical or neurological illness (as identified by the treating consultant psychiatrist).
    • Electrocardiogram (ECG): QTc interval >450 as measured in the last 12 months.
    • Aged below 18 years
    • Aged over 35 years
    E.5 End points
    E.5.1Primary end point(s)
    The number of new cases of depression as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of greater than 5 and confirmed by Mini International Neuropsychiatric Interview (MINI) in each treatment arm over the 6-month intervention phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month post randomisation.
    E.5.2Secondary end point(s)
    Secondary Outcomes:
    1. Assess the presence and change in symptoms of psychosis using the Positive and Negative Syndrome Scale (PANSS; the established 30 item semi-structured interview). It has both total score and subscales for positive, negative and general symptoms.

    2. Assess the presence of suicidal ideation and attempts in lifetime ever and preceding 12 months, together with current suicidal ideation and beliefs about future risk, using the Suicidal Behaviours Questionnaire-Revised (SBQ-R; a 4 item validated tool). It has established linear total and cut off scores to identify those with and without the reported risk.

    3. Assess trait and current (state) anxiety using the State-Trait Anxiety Inventory (STAI; commonly used 20 item self-report scale).

    4. Assess generalised anxiety using the General Anxiety Disorder (GAD7; a brief 7 item anxiety scale).

    5. Relapse of psychosis: as defined by a hospital admission or acute community care provided by Home Treatment/ Crisis Intervention team.

    6. Functioning: assess the overall impact of psychological disturbance on functioning. Given the complexity factors that may impact on functioning in emerging psychosis, the Social and Occupational Functioning Scale (SOFAS) and the Functional Remission of General Schizophrenia (FROGS) will both be rated.

    7. Quality of life: EQ-5D and ICECAP-A. EQ-5D is a 5 item health related quality of life assessment scale with well established reliability and population norms and the Investigating Choice Experiments Capability Measure for Adults (ICECAP-A), a more detailed measure of heath individual capability, used to supplement economic evaluation as the benefits of health and social care are not confined only to patients themselves.

    8. Side effects: Barnes Akathisia Scale (BARS), Antipsychotic non-neurological side effects rating scale-compiled (ANNSERS-c) and Simpson Angus Scale (SAS)

    9. Depression: Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR) is a widely used brief general depression measure that will be rated alongside the CDSS, to allow comparison in secondary analysis with depression prevention trials in other disorders.

    10. Economic: healthcare resource use will be collected at each follow-up assessment, when patients will be asked to recall visits to health professionals, medications and admissions. The information provided will be checked by searching their electronic patient records, and these data will be recorded on a standard case report form based on the Client Service Receipt Inventory. Resource use will be costed using national sources.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months post randomisation.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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 Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    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 Yes
    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 end of trial will be 6 months after the last data capture including data queries. This will allow sufficient time for the completion of protocol procedures, data collection and data input.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days31
    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: 508
    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 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 state508
    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)
    After the trial has ended, the participants will continue with their usual care in EIP. Unblinding will occur after the primary outcome assessment at 6 months, and following discussions with the participants, the clinical team will decide whether or not to continue antidepressant treatment, or commence this if needed in the placebo arm.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-02
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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