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    Summary
    EudraCT Number:2006-001196-38
    Sponsor's Protocol Code Number:D1448C00014
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-08
    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 number2006-001196-38
    A.3Full title of the trial
    A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono-Therapy in the Treatment of Elderly Patients with Major Depressive Disorder (SAPPHIRE STUDY).
    A.3.2Name or abbreviated title of the trial where available
    SAPPHIRE STUDY
    A.4.1Sponsor's protocol code numberD1448C00014
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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.3.1Product nameSeroquel SR
    D.3.2Product code ZD5077
    D.3.4Pharmaceutical form Prolonged-release 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.3.8INN - Proposed INNQuetiapine Fumarate Sustained Release
    D.3.9.1CAS number 111974-72-2
    D.3.9.2Current sponsor codeZD5077
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 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 (MDD)
    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 primary objective of this study is to evaluate the efficacy of quetiapine SR 50-300 mg/day versus placebo in elderly patients with MDD.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate:
    1. If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo.
    2. If quetiapine SR improves satisfaction with medication in patients with MDD, compared to placebo.
    3. If quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo.
    4. If quetiapine SR improves sleep quality in patients with MDD, compared to placebo.
    5. If quetiapine SR is effective in reducing suicidal ideation in patients with MDD, compared to placebo.
    6. If quetiapine SR improves somatic symptoms in patients with MDD, compared to placebo.
    7. If quetiapine SR is as safe and well tolerated as placebo in the treatment of patients with MDD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of written informed consent before initiation of any study related procedures.
    2.Male and female patients aged 66 years or older.
    3.Documented clinical diagnosis meeting criteria from the DSM-IV as assessed by M.I.N.I. for any of the following; 296.2x Major Depressive Disorder, Single Episode, or
    296.3x Major Depressive Disorder, Recurrent.
    4.HAM D total score of ≥22 and HAM D item 1 score ≥2 both at enrolment (Visit 1) and randomisation (Visit 2).
    5.Be able to understand and comply with the requirements of the study, as judged by the investigator.
    6.Outpatient status and living in home environment at enrolment.
    E.4Principal exclusion criteria
    1. MMSE score ≤25.
    2.Patients meeting the DSM-IV Diagnostic Criteria for Dementia of the Alzheimer’s type; DSM-IV Diagnostic Criteria for Vascular Dementia; DSM-IV Diagnostic Criteria for Dementia Due to Other General Medical Conditions (e.g., head trauma, intracranial structural abnormality, etc.); Practice Parameter for Mild Cognitive Impairment (Neurology 2001;56: 1133-1142); Diagnostic Criteria of The Consortium for Dementia with Lewy Bodies; and the Consensus Diagnostic Criteria for Frontotemporal Dementia.
    3.Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment.
    4.Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status.
    5.Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment.
    6.History of in-adequate response to an adequate dose (6 weeks) with 2 or more classes of antidepressants during current or previous depressive episode(s).
    7.Patients treated with antihypertensive medications must be on a stable dose for at least 30 days prior to enrolment.
    8.Substance or alcohol abuse or dependence.
    9.Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4 enzymes within 2 weeks prior to randomisation.
    10.Evidence of clinically relevant disease.
    11.A clinical finding that is unstable.
    12.Conditions that could affect absorption and metabolism of study medication.
    13.Significant hearing dysfunction, visual impairment, or communication disabilities that would interfere with the accurate assessment of the patient or impact the conduct of the study.
    14.A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years.
    15.Current or past diagnosis of stroke.
    16.History of seizure disorder, except febrile convulsions.
    17.Prior history of Neuroleptic Malignant Syndrome.
    18.Receipt of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) for treatment of depression within 90 days prior to randomisation, or the presence of a vagal nerve stimulator (VNS) device.
    19.Use of antipsychotic, mood stabilizer, or antidepressant drugs within 7 days before randomisation, or use of fluoxetine within 28 days before randomisation, or use of MAO inhibitors, anxiolytic or hypnotics within 14 days before randomisation (with the exception of those allowed with restriction per protocol), or use of a depot antipsychotic injection within two dosing intervals before randomisation.
    20.Patients unable to swallow oral medications whole or have difficulty swallowing.
    21.Patients who in the investigators opinion will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomisation and will continue until study completion.
    22.Patients who, in the investigator’s judgement pose a current serious suicidal or homicidal risk or have a HAM D item 3 score of 3 or greater, or have made a suicide attempt within the past 6 months.
    23.Patients with any diagnosis of a neurological condition, such as Parkinson’s disease, Huntington’s disease, essential tremor, multiple sclerosis, prior brain injury, space-occupying lesion, etc.
    24.A patient with diabetes mellitus fulfilling certain criteria.
    25.Clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator.
    26.An absolute neutrophil count (ANC) of ≤1.5 x 109 per litre.
    27.A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the patient is being treated for hypothyroidism.
    28.Liver function tests (AST or ALT) three times the upper normal limit.
    29.ECG results considered being clinically significant as determined by the investigator based on assessment by a centrally located experienced cardiologist interpreting the ECG.
    30.An ECG with a QTcF of ≥500 msec at enrolment.
    31.Use of quetiapine in doses >25 mg/day for insomnia within 7 days before randomisation.
    32.Known history of intolerance or hypersensitivity to quetiapine or to any other component in the tablets.
    33.Known lack of response to quetiapine in the treatment of depression in a dosage of at least 50 mg/day for 4 weeks (at any time before study start), as judged by the investigator.
    34.Treatment with quetiapine with a dosage of at least 50 mg/day at enrolment (visit 1).
    35.Contraindications as detailed in the country-specific prescribing information for quetiapine.
    36.Involvement in the planning and conduct of the study.
    37.Previous randomisation in the present study or any AstraZeneca-sponsored MDD study on quetiapine.
    38.Participation in another clinical study or compassionate use programme within 4 weeks of randomisation or longer in accordance with local requirements.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate the efficacy of quetiapine SR 50-300 mg/day versus placebo in elderly patients with MDD.

    The primary variable is the change in the MADRS total score from randomisation to Week 9.
    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 No
    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 Information not present in EudraCT
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 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
    At the end of 9 weeks, patients will undergo a 2-week follow-up period. No down-titration of investigational product will be performed.

    The definition of the end of the trial is data base lock.
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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) No
    F.1.3Elderly (>=65 years) Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 375
    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 Decision2006-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-04
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