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    Summary
    EudraCT Number:2011-005766-38
    Sponsor's Protocol Code Number:331-10-232
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-26
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2011-005766-38
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults with Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Effectiveness of OPC-34712 as Maintenance Treatment in Adults with Schizophrenia
    A.4.1Sponsor's protocol code number331-10-232
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.1.3.4CountryUnited States
    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 supportOtsuka Pharmaceutical Development & Commercialization Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointDirector
    B.5.3 Address:
    B.5.3.1Street Address1 University Square Drive, Suite 500
    B.5.3.2Town/ cityPrinceton
    B.5.3.3Post codeNJ 08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1609249-6573
    B.5.5Fax number+1609249-0573
    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 nameBrexpiprazole 1mg
    D.3.2Product code OPC-34712
    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 INNBrexpiprazole
    D.3.9.1CAS number OPC-34712
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameOPC-34712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 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 nameBrexpiprazole 2mg
    D.3.2Product code OPC-34712
    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 INNBrexpiprazole
    D.3.9.1CAS number OPC-34712
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameOPC-34712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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 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 nameBrexpiprazole 3mg
    D.3.2Product code OPC-34712
    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 INNBrexpiprazole
    D.3.9.1CAS number OPC-34712
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameOPC-34712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.IMP: 4
    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 nameBrexpiprazole 4mg
    D.3.2Product code OPC-34712
    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 INNbrexpiprazole
    D.3.9.1CAS number OPC-34712
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameOPC-34712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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 efficacy of brexpiprazole compared
    with placebo as maintenance treatment in adults with
    schizophrenia.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of brexpiprazole as maintenance treatment in adults with schizophrenia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who are able to provide written informed consent
    2. Ability, in the opinion of the principal investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
    3. Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
    4. Male and female subjects 18 to 65 years of age
    5. Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening
    6. Subjects who showed previous response to antipsychotic treatment (other than clozapine) in the past year, according to the investigator’s opinion.
    7. Subjects who are currently being treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment and who, in the opinion of the investigator, require chronic treatment with antipsychotic medication and could potentially benefit from monotherapy treatment with oral brexpiprazole for schizophrenia.
    8. Subjects who are experiencing a current exacerbation of psychotic symptoms as demonstrated by a PANSS Total Score > 80 at screening.
    9. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.
    10. Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts at screening and during the trial period.
    Inclusion Criteria Assessed Prior to Entry into Phase A
    - Subject has completed washout of specific prohibited medications required for Phase A
    Inclusion Criteria Assessed Prior to Entry into Phase B
    - Subject has completed washout of all prohibited medications required for Phase B
    - Subject is ready to receive oral brexpiprazole as monotherapy for treatment of schizophrenia at the
    final dose achieved in Phase A
    OR
    - Subject is ready to receive oral brexpiprazole as monotherapy for treatment of schizophrenia at a
    starting dose of 1 mg/day for subjects entering Phase B directly after screening.
    Inclusion Criteria Assessed Prior to Entry into Phase C
    - Subject is receiving monotherapy with single-blind brexpiprazole (1 to 4 mg/day) and the dose has
    been stable for at least the last 4 weeks prior to randomization into Phase C.
    Subject meets ALL of the following criteria for 12 weeks
    - Outpatient status
    - PANSS Total Score ≤ 70
    - A score of ≤ 4 (moderate) on each of the following PANSS items
    • Conceptual disorganization
    • Suspiciousness
    • Hallucinatory behavior
    • Unusual thought content
    - CGI-S score ≤ 4
    - No current suicidal behavior as assessed by the C-SSRS
    - No evidence of aggressive or violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.
    E.4Principal exclusion criteria
    1. Sexually active females of childbearing potential and male subjects who are not practicing two different methods of birth control with their partner during the trial and for 30 days after the last dose of trial medication or who will not remain abstinent during the trial and for 30 days after the last dose
    2. Females who are breast-feeding and/or who have a positive pregnancy test result
    3. Subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator.
    4. Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia including, but not limited to schizoaffective disorder, MDD, bipolar disorder, posttraumatic stress disorder, anxiety disorders, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder or mental retardation.
    5. Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator’s opinion, that require treatment with an antidepressant.
    6. Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only.
    7. Subjects with a significant risk of violent behavior; who represent a risk of committing suicide as indicated by any suicidal ideation within the last 6 months or any suicidal behaviors within the last two years; or who in the clinical judgment of the investigator present a serious risk of suicide.
    8. Subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of  3 on Item 8 of the AIMS at Screening.
    9. Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at Screening, Baseline of Phase A, End of Phase A, or Baseline of Phase B.
    10. Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
    11. Subjects with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days) and/or an abnormal result for free T4 at Screening
    12. Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C
    13. Subjects currently treated with insulin for diabetes. Subjects being treated for diabetes with medications other than insulin are eligible for the trial if their condition is stable
    14. Subjects with uncontrolled hypertension, symptomatic hypotension, or orthostatic hypotension
    15. Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting or coronary artery bypass surgery.
    16. Subjects with epilepsy or a history of seizures, except for a single seizure episode, for instance childhood febrile seizure, post traumatic, or alcohol withdrawal.
    17. Subjects with a positive drug screen for cocaine or other drugs of abuse
    18. Subjects who previously participated in any prior brexpiprazole clinical trial
    19. Subjects with a history of neuroleptic malignant syndrome
    20. Subjects who participated in a clinical trial within the last 180 days or who participated in more than two clinical trials within the past year.
    21. Subjects with a history of neuroleptic malignant syndrome (NMS).
    22. Subjects with a history of true allergic response (ie, not intolerance) to more than one class of medications.
    23. Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this trial is the time from randomization to exacerbation of psychotic symptoms/impending relapse in Phase C, defined as meeting any of the following four criteria:
    1) CGI-I score ≥ 5 (minimally worse) AND
    • an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score of > 4 with an absolute increase of ≥ 2 on that specific item since randomization OR
    • an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score of > 4 and an absolute increase of ≥ 4 on the combined four PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) since randomization
    OR
    2) Hospitalization due to worsening of psychotic symptoms (including partial hospitalization programs), but excluding hospitalization for psychosocial reasons (eg, homelessness or need for shelter that is unrelated to the subject’s underlying psychiatric condition) OR
    3) Current suicidal behavior as assessed by the C-SSRS (ie, an answer of “yes” to any of the questions on the Suicidal Behavior section of the C-SSRS) OR
    4) Violent or aggressive behavior resulting in clinically significant self-injury, injury to another person, or property damage.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization to exacerbation of psychotic symptoms
    E.5.2Secondary end point(s)
    Percentage of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria

    Other secondary efficacy endpoints evaluated for Phase C will include:
    • Proportion of subjects meeting stability criteria at endpoint in each treatment group
    • Change from baseline to endpoint in PANSS Total Score
    • Change from baseline to endpoint in CGI-S score
    • Change from baseline to endpoint in PANSS positive subscale score
    • Change from baseline to endpoint in PANSS negative subscale score
    • Change from baseline to endpoint in CGI-S score
    • CGI-I score at endpoint
    • Change from baseline to endpoint in PSP score
    • Change from baseline to endpoint in Global Assessment of Functioning scale (GAF) score
    • Time to discontinuation due to all causes
    • Change from baseline to endpoint in PANSS Excited Component (PEC) score
    • Change from baseline to endpoint in PANSS Marder Factor Scores
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    The End of Trial Date is defined as the last Date of Contact or the Date of Final Contact Attempt from the Post-treatment Follow-up eCRF page for the last subject completing or withdrawing from the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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: 363
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 364
    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)
    Subjects who complete the treatment phase or are withdrawn due to lack of efficacy/impending relapse. If IA is positive, all subjects will be given the option of entering open label. Subjects not entering the open-label trial and those who are discontinued or withdrawn from any trial phase will be prescribed appropriate antipsychotic treatment and will be followed up for safety 30 days after the last dose of trial medication via telephone contact or clinic visit
    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 Decision2013-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-12
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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