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    Summary
    EudraCT Number:2006-005578-39
    Sponsor's Protocol Code Number:PKI108574
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-12-06
    Trial results View 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 ConcernedEstonia - SAM
    A.2EudraCT number2006-005578-39
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled study to explore the antidepressant properties of the P38a kinase inhibitor GW856553X 15mg compared to placebo in subjects with Major Depressive Disorder exhibiting symptoms of loss of energy and interest, and psychomotor retardation, for a six week treatment period.
    A.4.1Sponsor's protocol code numberPKI108574
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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.3.2Product code GW856553
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGW856553
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGW856553
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Major Depressive Disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    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 the antidepressant effects of GW856553X versus placebo treatment at Week 6 in adult subjects diagnosed with MDD with symptoms of loss of energy / interest and with psychomotor retardation.

    To measure the decrease of circulating plasma cytokines (either TNF-alpha or IL-6) produced by GW856553X versus placebo treatment in adult subjects diagnosed with MDD including symptoms of loss of energy / interest and with psychomotor retardation, as:
    - whole population sample,
    - sample of subjects with elevated cytokine levels at baseline or at screening
    - sample of subjects that respond to the treatment vs. non-responders at Week 6 according to the various clinical scores
    E.2.2Secondary objectives of the trial
    Safety and tolerability of GW856553X in patients with MDD.

    To evaluate the antidepressant effects of GW856553X versus placebo treatment at Weeks 1, 2, 3, 4 and 5 in adult subjects diagnosed with MDD including symptoms of loss of energy / interest and with psychomotor retardation.

    To evaluate the antidepressant effects of GW856553X versus placebo treatment in the sample of adult subjects diagnosed with MDD with symptoms of loss of energy / interest and with psychomotor retardation with abnormally elevated cytokine level at randomisation (Week 0).

    To evaluate the effects of GW856553X versus placebo treatment on specific clusters of symptoms possibly associate with pro-inflammatory cytokine effects (putative cytokine-related intermediate phenotypes) in the same adult subjects diagnosed with MDD, in particular:
    - Psychomotor retardation
    - Fatigue
    - Daytime sleepiness

    See the protocol for a complete listing of secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A full list of Inclusion Criteria for MDD subjects can be found in the protocol. The criteria below are those that have been amended.

    9. Subject currently meets the diagnosis for MDD (without psychotic features), recurrent, as defined in the DSM-IV-TR, diagnosed with a comprehensive psychiatric evaluation incorporating the MINI, as assessed* by a physician with adequate training in psychiatry. *Assessment by a physician with adequate training in psychiatry must include a face-to-face evaluation of the subject, but may be aided by subject evaluation conducted by a healthcare professional with a clinically relevant qualification (e.g., psychiatric nurse or psychologist) and a minimum of two years of documented experience assessing subjects with MDD and appropriate training in IDS-C scoring
    10. Subject must, in the investigator’s opinion based on clinical history, have met DSM IV-TR criteria for their current Major Depressive Episode for at least 4 weeks but for no greater than 24 months.
    11. Subject must have had at least one previous major depressive episode with a diagnosis of MDD in his/her history, and had a successful pharmacological treatment of that episode, and is currently experiencing a recurrence of MDD presently un-medicated or inappropriately treated.
    12. Subjects must exhibit moderate to severe levels of depression as defined by:
    • a minimum score of 17 on the QIDS-SR16 and a minimum score of 1 for the Items representing mood depression, interest, energy and psychomotor retardation when measured at the Screening visit (Week -1) and the Randomisation visit (Week 0).
    • a minimum total score of 36 on the IDS-C when measured at the Screening visit (Week -1) and at the Randomisation visit (Week 0) with a minimum score of 1 on Items representing mood depression, interest, energy, and psychomotor retardation.

    A full list of Inclusion Criteria for healthy subjects can be found in the protocol. The criterion below has been added.

    2. Subject has total score <=10 on the QIDS SR 16 IVRS at the Screening (week -1) and additional visit (Week 0)
    E.4Principal exclusion criteria
    A full list of Exclusion Criteria for MDD subjects can be found in the protocol. The criteria below are those that have been amended.

    4. The subject has a history of elevated liver function tests on more than one occasion (ALT, AST, and total bilirubin > 2 x ULN or ALP > 3 x ULN) in the past 7 months.
    5. The subject has significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions that, in the opinion of the investigator, place the subject at an unacceptable risk as a participant in this trial.
    12. Subject has a positive urine test at the Screening or Randomisation (Week 0) visits for illicit drug use with the exception of barbiturates, whose sporadic use as hypnotics has been ascertained, the subject recommended for discontinuation pending verification for barbiturate dependence that will lead to exclusion from the study at any time; a history of DSM IV-TR diagnosis of substance abuse or dependence (other than nicotine) within the past 2 years.
    13. Subject’s IDS-C assessment decreases by more than 25% between the Screening (Week -1) and Randomisation (Week 0) visits.
    23. Women who have a positive serum Human Chorionic Gonadotropin (HCG) pregnancy test at the Screening visit (Week -1), a positive urine dipstick test at the Second Study Visit (Week 0), or who are lactating or planning to become pregnant within the next 12 weeks following the Screening visit.
    25. The subject is currently receiving a chronic biological or pharmacologic anti-inflammatory therapy (includes both non-steroidal anti-inflammatory agents and corticosteroids); interferon therapy at any dose or did receive them within 6 months prior randomisation; vaccinations performed within 1 month or less prior to the Screening Visit.
    26. Subjects who have taken other psychoactive drugs unles otherwise stated in the protocol between the Screening and the Randomisation visit (approximately 1-2 weeks).

    A full list of Exclusion Criteria for healthy subjects can be found in the protocol. The criteria below are those that have been amended.

    13. Subject has a systolic blood pressure (SBP) > 160mmHg or a diastolic blood pressure (DBP) > 95mmHg at the Screening (Week –1) or Second Study Visit (Week 0) visit compatible with diagnosis of hypertension.
    14. Women who have a positive serum Human Chorionic Gonadotropin (HCG) pregnancy test at the Screening visit (Week -1), a positive urine dipstick test at the Second Study Visit (Week 0), or who are lactating
    15. Subjects have any screening electrocardiographic (ECG) parameter outside of the Sponsor-specified ranges; the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the Second Study Visit.
    16. The subject is currently receiving a chronic biological or pharmacologic anti-inflammatory therapy (includes both non-steroidal anti-inflammatory agents and corticosteroids); interferon therapy at any dose or did receive them within 6 months prior to the screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Changes from randomisation (Week 0) produced by GW856553X versus placebo at Week 6 in the following clinical scales:
    • Bech (6-item HAMD-17) score
    • IDS C total score
    • QIDS-SR16 total score

    Changes from randomisation (Week 0) associated with GW856553X versus placebo at week 6 in the morning plasma levels of the following pro-inflammatory biomarkers adjusted for age, gender, BMI, and smoking habit:
    • IL-6.
    • TNF-alpha.
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 120
    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 Decision2007-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-06-30
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