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    Summary
    EudraCT Number:2008-007190-20
    Sponsor's Protocol Code Number:D144AC00003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-007190-20
    A.3Full title of the trial
    An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium versus Placebo as an add on to SEROQUEL XR™ (Quetiapine Fumarate) in Adult Patients with Acute Mania
    A.4.1Sponsor's protocol code numberD144AC00003
    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 XR 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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 XR 200 mg
    D.3.4Pharmaceutical form 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
    D.3.9.1CAS number 111974-69-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 2
    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 Lithium carbonate capsule, USP
    D.2.1.1.2Name of the Marketing Authorisation holderRoxane Laboratories, USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLithium
    D.3.4Pharmaceutical form Capsule*
    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 INNLithium carbonate
    D.3.9.1CAS number 554132
    D.3.9.3Other descriptive nameLithium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.IMP: 3
    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 XR 300 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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 XR 300 mg
    D.3.4Pharmaceutical form 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
    D.3.9.1CAS number 111974-69-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    Acut mania in subjects with bipolar I disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10004939
    E.1.2Term Bipolar I disorder
    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 is to evaluate the effectiveness of lithium compared to placebo as an add on to quetiapine XR in the treatment of acute mania in subjects with bipolar I disorder, as assessed by the change from baseline to final assessment (Day 43) in Young Mania Rating Scale (YMRS) total score.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare effectiveness of Lithium compared to placebo as an add-on to quetiapineXR reduction from baseline using different scales (e.g. YMRS, MADRS,CIG-BP, PANSS). Short time safety of Lithium as add-on to quetiapine XR.
    Blood samples for optionl exploratory genetic studies focusing in identifications of genes that influence the disposition, efficacy, safety and tolerability of quetiapine XR in subjects with bipolar I disorder.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study-specific procedures.
    2. Male and female subjects aged 18 to 65 years, inclusive.
    3. Documented clinical diagnosis meeting the DSM-IV-TR (American Psychiatric Association 2000) criteria for bipolar I disorder, most recent episode manic (296.4x) or mixed (296.6x).
    4. YMRS total score ≥20 and ≥4 on 2 of 4 core items (irritability, speech, content, disruptive/aggressive behavior) at enrollment (Visit 1) and randomization (Visit 2).
    5. Subjects must have a CGI-BP ≥4 (moderately ill) at enrollment (Visit 1) and at randomization (Visit 2).
    6. Subjects must have experienced ≥1 manic or mixed episode (other than the current episode) in the past 5 years.
    7. Female subjects of childbearing potential must have a negative serum pregnancy test at enrollment (Visit 1) and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long term injectable contraceptive, intrauterine device, or tubal ligation.
    8. Subjects must be able to understand and comply with the requirements of the study, as judged by the investigator.
    9. Subjects may be outpatients or inpatients at enrollment (Visit 1), but all subjects must be inpatients when randomized (Visit 2) and remain inpatients until discharged at the discretion of the investigator.
    E.4Principal exclusion criteria
    1. Subjects must not have another current, major DSM-IV-TR Axis I disorder that is symptomatic or has required treatment within 6 months of enrollment, other than the bipolar disorder under study.
    2. Subjects with >8 mood episodes during the past 12 months.
    3. Subjects with a mania-like syndrome that is a physiological consequence of a medical condition, a medication, a treatment, substance abuse, or withdrawal.
    4. Subjects that are continuously hospitalized for acute bipolar mania for >3 weeks immediately prior to randomization (Visit 2).
    5. Subject with alcohol or other substance dependence or abuse as defined by DSM IV-TR criteria at enrollment (Visit 1) that is not in sustained full or sustained partial remission (12 months or longer), except caffeine and nicotine dependence. Subjects with a positive urine toxicology screen are not excluded unless they satisfy DSM-IV-TR criteria for abuse or dependence, except that subjects are excluded with a single urine toxicology screen positive for cocaine, heroin, or PCP.
    6. Subjects who use or need to use, within 2 weeks prior to randomization, drugs that strongly induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes. Examples of inducers are carbamazepine, phenytoin, barbiturates, rifampin, rigabutin, glucocorticoids, thioridazine, and St. John’s wort. Examples of inhibitors are ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, indinavir, nelfinavir, ritonavir, and saquinavir.
    7. Subjects with evidence of a clinical disorder or clinical finding problematic to the study, as judged by the investigator, such as renal (serum creatinine ≥1.5 mg/dL) or hepatic impairment (alanine transaminase [ALT] or aspartate transaminase [AST] 3 times the upper limit of normal), significant coronary artery disease, cerebrovascular disease, active viral hepatitis B or chronic active hepatitis C, or Acquired Immunodeficiency Syndrome (AIDS).
    8. Subject with clinical findings that, in the opinion of the investigator, suggest unstable medical conditions, or that might be negatively affected by the study medication or that would negatively affect the study medication. Examples of unstable conditions are poorly controlled hypertension or unstable angina.
    9. Subjects with conditions that could affect absorption or metabolism of the investigational product (e.g., malabsorption syndrome, severe liver disease), as judged by the investigator.
    10. Subjects with current or past diagnosis of stroke or medically documented transient ischemic attacks (TIA).
    11. Subjects with a history of seizure disorder, except febrile convulsions.
    12. Subjects using any of the following medications:
    - Antipsychotic use (other than SEROQUEL) within 7 days prior to randomization (Visit 2).
    - Antidepressant, anxiolytic, hypnotic, or other psychoactive drugs within 7 days prior to randomization (Visit 2), with the exception of lorazepam (or locally available equivalent approved by the Sponsor), if needed, up to a maximum dose of 6 mg which can be used up to the day prior to randomization.
    - Mood stabilizers (other than lithium) within 2 days prior to randomization (Visit 2).
    - Fluoxetine within 28 days prior to randomization (Visit 2).
    - A depot antipsychotic injection within 1 dosing interval (for the depot) prior to randomization (Visit 2).
    - Irreversible monoamine oxidase inhibitors (MAOI) within 14 days prior to randomization (Visit 2).
    - Lithium within 14 days prior to randomization (Visit 2).
    13. Subjects who received electroconvulsive therapy (ECT) within 90 days prior to randomization.
    14. Subjects who, in the investigator’s opinion, will require formalized psychotherapy during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomization (Visit 2).
    15. Subjects who, in the investigator’s judgment, pose a current serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
    16. Female subjects who are pregnant, nursing, or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is change from badeline to final assessment (day 43) in Young Mania Rating Scale (YMRS) total score.
    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 Yes
    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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    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
    Last subject completing last visit
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-18. Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 350
    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 Decision2009-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
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