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    Summary
    EudraCT Number:2006-006426-26
    Sponsor's Protocol Code Number:D1443L00009
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-12-21
    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 ConcernedSweden - MPA
    A.2EudraCT number2006-006426-26
    A.3Full title of the trial
    FAST – A randomised, open-label, parallel, multicentre Phase IIIb Study to evaluate the Efficacy and Safety of Quetiapine IR titrared over 4 Days in Patients with Acute Psychosis (Rapid versus Conventional Titration)
    A.3.2Name or abbreviated title of the trial where available
    FAST
    A.4.1Sponsor's protocol code numberD1443L00009
    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 Yes
    D.2.1.1.1Trade name Seroquel
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, Södertälje
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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
    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.3.11 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 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
    Patients requiring treatment, as judged by the Investigator, for an acute episode of schizophrenia, schizoaffective disorder, psychosis NOS or bipolar mania (according to DSM-IV criteria).
    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 objective is to compare the efficacy of quetiapine IR in patients with acute schizophrenia, schizoaffective disorder, psychosis NOS or bipolar mania with psychotic symptoms, following rapid titration versus conventional titration, by assessment of Positive and PANSS-EC at Day 5 compared with baseline at Day 1.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration:
    1. by assessment of PANSS-EC at baseline and at Day 3 and 8.
    2. by assessment of CGI at baseline and at Day 5 and 8.
    3. by assessment of FAST rating scale at baseline and at Day 5 and 8.
    4. by self assessment of QoL-DT at baseline and at Day 5 and 8.
    5. by assessment of the sleeping pattern.

    6. To compare the tolerability of quetiapine IR, following rapid titration versus conventional titration, by assessment of treatment failures.
    7. To compare the tolerability of quetiapine IR, following rapid titration versus conventional titration, by assessment of the frequency of adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent before initiation of any study-related procedure.
    2. Male or female, aged 18-65 years.
    3. Requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode of schizophrenia, schizoaffective disorder, psychosis NOS or bipolar mania (according to DSM-IV diagnostic criteria).
    4. Patients who are able to swallow tablets from Day 1 of the study period and who are expected not to be in need of other antipsychotic medication during the study, as judged by the Investigator.
    E.4Principal exclusion criteria
    1. In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5.
    2. Patients with known relevant clinical disease (renal or hepatic impairment; cardiovascular- or cerebrovascular disease; congestive heart failure; diabetes mellitus; history of seizures), or other significant or unstable disease, including malignancy, as judged by the Investigator.
    3. History of multiple episodes of syncope, or significant orthostatic hypotension, as judged by the Investigator.
    4. Patients with known neutropenia. Patients with an absolute neutrophil count (ANC) of less or equal to 1.5 x 10 9/L will be excluded from the study. Patients with fever at enrolment must not be included in the study if no ANC result is available.
    5. Treatment with clozapine within 28 Days prior to enrolment in this study.
    6. Administration of Cytochrome P450 inducers or Cytochrome P450 inhibitors in the 14 Days preceding enrolment into the study, or concomitant use during the study, including, but not limited to, the following:
    - Cytochrome P450 inducers: phenytoin, carbamazepine, barbiturates, rifampin, St John’s Wort and glucocorticoids
    - Cytochrome P450 inhibitors: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nalfinavir, ritonavir, fluvoxamine, saquinavir and grape fruit juice
    7. Known intolerance or lack of response to quetiapine, as judged by the Investigator.
    8. Pregnancy or lactation. Females of childbearing potential must use a reliable method of contraception i.e. hormonal contraceptives, double-barrier methods, intra-uterine device or tubal ligation, unless their sexual partner is sterile (vasectomy).
    9. Patients who pose an imminent risk of suicide, or danger to self or others, as judged by the Investigator.
    10. Acute intoxication due to alcohol or drug dependence at enrolment.
    11. Involvement in the planning and conduct of this study (applies to both AstraZeneca staff or staff at the study site)
    12. Previous enrolment or randomisation in the present study.
    13. Participation in a clinical study of any investigational drug 30 days prior to enrolment and during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable of the study is the change in PANSS-EC from baseline to Day 5.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    rapid titration versus conventional titration
    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 concerned25
    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 Information not present in EudraCT
    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 end of the study is defined as the date of database 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 months0
    E.8.9.1In the Member State concerned days0
    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) 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 state160
    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 Decision2007-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-04-23
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