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    Summary
    EudraCT Number:2012-004079-38
    Sponsor's Protocol Code Number:01112012
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-12-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-004079-38
    A.3Full title of the trial
    Agomelatine treatment of major depressive episodes in the course of schizophrenic psychoses (AGOPSYCH).
    A single arm, prospective pilot study
    Agomelatin zur Behandlung majorer, depressiver Episoden im Verlauf schizophrener Psychosen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antidepressive treatment of Schizophrenia patients with agomelatine
    Antidepressive Behandlung schizophrener Patienten mit Agomelatin
    A.3.2Name or abbreviated title of the trial where available
    AGOPSYCH
    AGOPSYCH
    A.4.1Sponsor's protocol code number01112012
    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 SponsorCentral Institute of Mental Health, Department of Psychiatry and Psychotherapy
    B.1.3.4CountryGermany
    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 supportCentral Institute of Mental Health, Research Group Molecular Schizophrenia Research
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportServier
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentral Institute of Mental Health, Department of Psychiatry and Psychotherapy
    B.5.2Functional name of contact pointProf. Dr. Mathias Zink, PI
    B.5.3 Address:
    B.5.3.1Street AddressSquare J5
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68159
    B.5.3.4CountryGermany
    B.5.4Telephone number++4962117032911
    B.5.5Fax number++4962117032525
    B.5.6E-mailmathias.zink@zi-mannheim.de
    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 Valdoxan 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderServier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNAGOMELATINE
    D.3.9.1CAS number 138112-76-2
    D.3.9.4EV Substance CodeSUB05286MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major depressive episode
    Majore, depressive Episode
    E.1.1.1Medical condition in easily understood language
    Depression
    Depression
    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
    Comparison of MDE severity before and after six weeks of treatment with Agomelatine (AGO) in patients with schizophrenia-spectrum disorder. HAM-D17 and CDSS will be applied at baseline and regularly over a period of 6 weeks after treatment initiation. In order to assess the treatment success, means in HAM-D17 and CDSS scores at both baseline and week 6 will be compared within the efficacy sample (at least one application of AGO, LOCF). The primary endpoint will be tested with a two-sided student’s t-test at a level of statistical significance of ≤0.05.
    Vergleich der Erkrankungsschwere der MDE vor und nach 6 Wochen Behandlung mit Agomelatin (AGO) bei Patienten mit Schizophrenie-Spektrum-Erkrankungen. Die Skalen HAM-D17 und CDSS werden bei Baseline und gemäß Studienprotokoll nach den Wochen 2,4 und 6 erhoben. Um den Behandlungserfolg zu messen, werden die Mittelwerte der HAM-D17 und CDSS bei Baseline und nach 6 Wochen Behandlung im Wirksamkeitskollektiv (alle Patienten, die mindestens einmal AGO einnahmen, LOCF). Der primäre Endpunkt wird mit einem zweiseitigen t-test bei einem Signifikanzniveau von ≤0.05 getestet.
    E.2.2Secondary objectives of the trial
    Efficacy:
    a) Responses, remission rates represented in HAM-D17-improvement by 50% or below 8 points.
    b) Long-term-efficacy due to follow-up-investigations after 12 weeks of treatment (HAMD17 and CDSS)
    c) Personal and social functioning (according to CGI and PSP)
    Safety and tolerability:
    a) Stability of the psychotic syndrome according to PANSS
    b) General tolerability (physical examination, ECG, laboratory testing)
    c) Pharmacokinetic interaction (regarding serum levels of antipsychotics)

    Neurocognition:
    Improvement of cognitive deficits associated with schizophrenia (MATRICS)
    Wirksamkeit:
    a) Response- und Remissionsraten gemäß HAMD17-Reduktion um 50% oder unter 8 Punkte.
    b) Langzeitwirksamkeit (follow-up nach 12 Wochen) gemäß HAMD17 oder CDSS
    c) Psychosoziales Funktionsniveau nach CGI und PSP

    Sicherheit und Verträglichkeit
    a) Stabilität der psychotischen Symptome hinsichtlich PANSS
    b) Allgemeine Verträglichkeit (Klinische Untersuchung, EKG, Laboruntersuchungen)
    c) Pharmakokinetische Interaktionen hinsichtlich der Antipsychotika-Serumspiegel.

    Neurokognition:
    Verbesserung der mit Schizophrenie assoziierten neurokognitiven Defizite (MATRICS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age between 18 and 60 years.
    2. Presence of an MDE according to ICD-10 criteria (HAMD17 ≥ 18 or CDSS-Score ≥ 8 points).
    3. Lifetime diagnosis of schizophrenia-spectrum disorder according to ICD-10 (F 20, F22, F23, F25).
    4. Partial remission of psychotic positive symptoms (PANSS positive subscore ≤ 15 points).
    5. Stable antipsychotic medication for at least 2 weeks (tolerable quantitative changes of daily dosage ≤ 25%).
    6. The patient is able to give an informed consent. In case of legal guardianship, the custodian will have to agree to the patient’s participation.
    E.4Principal exclusion criteria
    1. Contraindications against AGO treatment [compare study protocol section 1.4.5: bipolar depression, mania, suicidality (see 3.2.4), hepatic dysfunction with increased serum transminases above threefold upper limits of normal values, concomitant prescription of moderate CYP1A2 inhibitors (e.g. propranolol, grepafloxacine, enoxacine)]
    2. Insufficient contraception in women of childbearing potential when sexually active. Adequate methods of contraception are: intrauterine devices (IUD), oral or depot anticontraceptives
    3. Gravidity or breastfeeding.
    4. Addiction to alcohol
    5. Abuse of THC and other illegal substances according to ICD-10 (anamnestic data).
    6. Dementia according to ICD-10.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of MDE severity before and after six weeks of treatment with AGO in patients with schizophrenia-spectrum psychosis. HAM-D17 and CDSS will be applied at baseline and regularly over a period of 6 weeks after treatment initiation. In order to assess the treatment success, means in HAM-D17 and CDSS scores at both baseline and week 6 will be compared within the efficacy sample (at least one application of AGO, LOCF). The primary endpoint will be tested with a two-sided student’s t-test at a level of statistical significance of ≤0.05.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (before start of treatment with agomelatine) and after 6 weeks of treatment.
    E.5.2Secondary end point(s)
    Efficacy:

    a) Responses, remission rates:
    HAM-D17 and CDSS will be applied regularly over a 6-week observation period after AGO initiation in order to evaluate treatment response. Proportion of patients responding to treatment (reduction of HAM-D17 by 50%) or even experiencing remission (HAM-D17 < 8 points) will be determined.
    b) Long-term-efficacy (follow-up after 12 weeks):
    In order to assess the long-term efficacy of AGO, a follow-up visit will be scheduled 3 months after treatment initiation. Changes in HAM-D17 and CDSS scores will also be evaluated (long-term follow-up). Suicidal ideations and their changes during treatment will be monitored with the CSSRS (Columbia Suicide Severity Rating Scale).
    c) Personal and social functioning:
    Personal and social performance will be evaluated with the PSP; all-over clinical impression will be rated on the CGI-S, and the level of improvement will be assessed by CGI-I and CGI-CB.

    Safety and tolerability:

    a) Stability of the psychotic syndrome:
    Psychotic positive symptoms will be monitored by regular PANSS ratings; negative symptoms will be assessed by PANSS (negative subscale) and SANS. An increase of PANSS positive subscores by ≥ 5 points will be regarded as a clinically relevant psychotic deterioration and result in an early drop-out.
    b) General tolerability:
    Clinical measures (e.g. body weight, BMI, heart rate, blood pressure) and routine laboratory parameters, serum prolactin levels as well as ECGs will be examined. Sleep quality will be monitored by self-rating (LSEQ scores), sexual functioning will be evaluated by the administration of the SFQ scale; general well-being under psychopharmacological treatment will be assessed by SWN. Investigators will evaluate treatment AEs with the instruments BAR, SAS and ANNSERS.
    c) Pharmacokinetic interactions:
    Serum antipsychotic levels will be obtained prior to augmentation with AGO, 6 weeks and 3 months after treatment initiation.

    Neurocognition:

    Neurocognitive performance will be evaluated both prior to and 3 months after AGO treatment initiation with the MATRICS (Measurement ant Treatment Research to Improve Cognition in Schizophrenia) consensus cognitive battery (MCCB) embracing the domains procession speed, working memory, verbal and visual learning and memory, attention span, problem solving and social cognition. In addition, the premorbid levels of intelligence will be estimated (MWT-B and Raven-SPM).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending from the specific secondary endpoints: Baseline, 2, 3, 4, 6, or 12 weeks of treatment.
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 27
    F.1.3Elderly (>=65 years) No
    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 state27
    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, meaning that subjects will receive normal treatment after the end of trial including the prescription of agomelatine
    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 Decision2013-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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