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    Summary
    EudraCT Number:2010-020987-39
    Sponsor's Protocol Code Number:31-09-266
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-10-15
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2010-020987-39
    A.3Full title of the trial
    A Long-Term Multicenter, Randomized, Double-blind, Placebocontrolled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients with Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A blinded study looking at the efficacy, safety and tolerability of aripirazole in Adolescent Patients with Schizophrenia.
    A.3.2Name or abbreviated title of the trial where available
    ATTAIN
    A.4.1Sponsor's protocol code number31-09-266
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01149655
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/99/2011
    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 organisationMatthew Media Group (MMG)
    B.5.2Functional name of contact pointNot applicable
    B.5.3 Address:
    B.5.3.1Street AddressNot applicable
    B.5.3.2Town/ cityNot applicable
    B.5.3.3Post codeNot applicable
    B.5.3.4CountryUnited States
    B.5.6E-mailATTAINstudyinfo@mmgct.com
    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 Abilify
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka America Pharmaceutical, Inc.
    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 namearipirazole 2 mg tablet
    D.3.2Product code OPC-14597
    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 INNAripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    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: 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 Abilify 5 mg tablet
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd, Uxbridge, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namearipirazole 5 mg tablet
    D.3.2Product code OPC-14597
    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 INNAripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    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) 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 Yes
    D.2.1.1.1Trade name Abilify 10 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd, Uxbridge, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namearipirazole 10 mg tablet
    D.3.2Product code OPC-14597
    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 INNAripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.2.1.1.1Trade name Abilify 15 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd, Uxbridge, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namearipirazole 15 mg tablet
    D.3.2Product code OPC-14597
    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 INNAripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 in Adolescent Patients
    E.1.1.1Medical condition in easily understood language
    Schizophrenia in Adolescents
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 Yes
    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 aripiprazole compared
    with placebo, as measured by time to exacerbation of psychotic symptoms/impending
    relapse, in adolescent schizophrenic subjects who have maintained stability for 2 consecutive weekly time points on oral aripiprazole with at least 7 weeks of treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of oral aripiprazole as maintenance treatment in adolescent subjects with schizophrenia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria Assessed at Screening

    1. Study specific written informed consent/assent obtained from the parent/guardian or legal representative, as applicable for local laws prior to the initiation of any protocol-required procedures. In addition, the subject must provide informed assent at screening and must be able to understand that he or she can withdraw from the study at any time. All informed consent/assent procedures
    must be in accordance with the study center’s institutional review board/ethics committee (IRB/IEC) and local regulatory requirements.

    2. Male and female subjects aged 13 to 17 years, inclusive, at the time of informed consent/assent until randomization in Phase 3.

    3. Subjects with a current diagnosis of schizophrenia, and a history of the illness for at least 6 months prior to screening.

    4. Subjects who in the investigator’s judgment, require treatment with antipsychotic medication(s).

    5. Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics, according to the investigator’s clinical judgment.

    6. Subjects who are currently being treated with oral antipsychotics other than clozapine. Subjects who have been without antipsychotic treatment for no more than 3 weeks prior to screening will be considered as being treated currently for the purpose of determining eligibility for this trial.

    7. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

    8. Inpatient or outpatient status.

    9. Ability of the subject, the subject’s parent/guardian or the legal representative, as applicable for local laws to comprehend and satisfactorily comply with the protocol
    requirements (including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medications), to read and understand the written word in order to complete subject-reported outcomes measures, and to reliably rate assessment scales.

    10. Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double barrier methods of contraception (or can confirm abstinence), and must not be pregnant or lactating.

    11. Subjects who are receiving antipsychotic(s) other than aripiprazole must be cross-titrated to aripiprazole monotherapy over 4 to 6 weeks using an initial dose of 2 mg/day in Phase 1 to achieve a recommended aripiprazole monotherapy minimum target dose of 10 mg/day in order to enter Phase 2, but higher doses may be achieved based on the subject’s clinical need and investigator judgment. Subjects who have received or are receiving clozapine are excluded from the study.

    12. Subjects who are treated with non-branded generic aripiprazole must also be cross-titrated to achieve a 10 mg target dose of study aripiprazole. Also, the total dose of the generic aripiprazole and study aripiprazole (at any given time in Phase 1) cannot exceed a total of 30 mg/day.

    13. By the end of screening, eligible subjects who are receiving oral branded aripiprazole (ie, Abilify™) monotherapy at a dose between 10 and 30 mg/day for treatment of schizophrenia at screening can enter Phase 2 directly.

    14. Adequate washout of prohibited concomitant medications prior to entry into Phase 2, including ≥ 14 days for prohibited mood stabilizers, ≥ 14 days for prohibited antidepressants [≥ 28 days for fluoxetine or Symbyax (olanzapine/fluoxetine)], ≥ 6 months for marketed or investigational depot antipsychotics.

    15. For subjects who enter Phase 2 directly from screening: Subjects who are receiving no more than one benzodiazepine after screening. NOTE: If a subject is receiving two benzodiazepines at screening, attempts should be made to discontinue one of them, if clinically warranted, to allow potential subjects to enter the study. The second benzodiazepine should be tapered off over an appropriate amount of time within the established duration of the screening period to prevent any withdrawal effects, and the subject should be maintained on the remaining benzodiazepine for at least 14 days prior to the first dose of study medication in Phase 2.

    The full list of inclusion criteria at screening plus Inclusion Criteria Assessed Prior to Entry into Phase 1 and Inclusion Criteria Assessed Prior to Entry into Phase 2 are described in the study protocol.
    E.4Principal exclusion criteria
    Sex and Reproductive Status

    1. Sexually active males who are not practicing double-barrier birth control or who will not remain abstinent during the study and for 90 days following the last dose of study medication, or sexually active females of childbearing potential who are not practicing double-barrier birth control or who will not remain abstinent during the study and for 30 days following the last dose of study medication. Abstinence will be permitted if it is confirmed and documented at every study visit. If employing birth control, two of the following precautions must be used:
    vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), birth control pill, birth control depot injections, birth control implant, condom or sponge with spermicide.

    2. Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving study drug.

    Target Disease

    3. Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including an Axis I (DSM-IV-TR) diagnosis of schizoaffective disorder, major depressive disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD. Subjects with a diagnosis of ADD/ADHD and treated with stimulants or other ADD/ADHD medications within 1 year are prohibited.

    4. amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (ie, medication, illicit drug use, etc.).

    5. Subjects with attention deficit disorder or attention deficit hyperactivity disorder and/or the patient was on stimulant treatment for any period of time over the last one year prior to screening.

    6. Subjects with a clinical presentation and/or history of any neurodevelopmental disorder except Tourette’s syndrome.

    7. Subjects experiencing acute depressive symptoms within the past 30 days prior to screening that, according to the investigator’s judgment, require treatment with an antidepressant.

    8. Subjects with schizophrenia that is considered treatment resistant to antipsychotic medication, including relapse while on adequate doses of aripiprazole, by history.

    9. Subjects who are currently receiving clozapine or have received clozapine, regardless of dose or duration, at any time in the past are ineligible for entry into the study.

    Medical History and Concurrent Disease

    10. Subjects who have a significant risk of committing suicide based on history (eg, suicide attempt in the past 1 year) or routine psychiatric status examination, or who have an answer of “yes” on Questions 4 or 5 (current or over the last 30 days) on the suicidal ideation section of the baseline screening version of the C-SSRS.

    11. Subjects who have met DSM-IV-TR criteria for substance dependence (including alcohol and
    benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.

    12. Subjects who have epilepsy, a history of seizures (except
    for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions that would expose them to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator (eg, history of myocardial infarction or ischemic heart disease, arrhythmia, congestive heart failure, or cancer); subjects with a co-morbid serious systemic illness that requires pharmacotherapy.

    13. Subjects with a history of subclinical hypothyroidism (TSH ≥ 4 mIU/L), known hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days prior to entry into Phase 1 or Phase 2).

    14. Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels (defined as fasting blood glucose ≥ 125 mg/dL). If the result is abnormal, then hemoglobin A1c (HbA1c) testing will automatically be performed. If the HbA1c is ≥ 7%, the subject must be withdrawn and considered a screen failure. At any time during the study, including screening, if a subject’s fasting blood glucose levels are abnormal (≥125 mg/dL), then fasting blood glucose testing must be repeated.

    A full list of Other Exclusion Criteria is contained in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is the time from randomization to exacerbation of psychotic symptoms/impending relapse in Phase 3, where impending relapse is defined as meeting any of the following 5 criteria:
    1) CGI-Improvement of ≥ 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 > 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 > 4 and an absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) since randomization OR
    2) a CGI-I score of 6 or 7 (much or very much worse)
    OR
    3) Hospitalization due to worsening of illness (including partial hospitalization programs), but excluding hospitalization for psychosocial reasons
    OR
    4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS
    OR
    5) Violent or aggressive behavior resulting in clinically significant self-injury, injury to
    another person, or property damage or inability to attend school due to this behavior.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 49 endpoint events
    E.5.2Secondary end point(s)
    The following secondary efficacy endpoints will be compared in Phase 3 between the aripiprazole treatment group and the placebo group at endpoint:
    • Percentage of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria
    • Percentage of responders in each treatment group (ie, response defined as meeting stability criteria)
    • Percentage of subjects achieving remission, where remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6)
    • Time to discontinuation for all causes
    Other Endpoints:
    Efficacy:
    • Mean change from baseline to endpoint in PANSS Total Score
    • Mean change from baseline to endpoint in CGI-S score
    • Mean CGI-I score at endpoint
    • Mean change from baseline to endpoint in PANSS positive and negative subscales
    • Mean change from baseline to endpoint in CGAS
    Safety:
    • The frequency and severity of AEs, seriousness of AEs (clinical and laboratory), and discontinuation from study due to AEs
    • The frequency of symptom items for the the New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment: (NY-AACENT)
    • The frequency of side effects for the UKU Side
    Effects Rating Scale
    • Analysis of potential suicide events recorded on the C-SSRS
    • Mean change from baseline and incidence of clinically significant changes from baseline for clinical laboratory tests and urinalysis results (including fasting blood lipids and glucose, serum prolactin, insulin, and creatinine phosphokinase [CPK]), vital signs and ECG parameters. A central ECG service will be utilized to review all ECGs in order to standardize interpretations for the safety analysis.
    • Review of physical examination findings
    • Baseline and postbaseline Tanner Staging
    • Mean change from baseline of z-scores for height and body weight, mean changes of BMI and waist circumference
    • Mean change from baseline to endpoint on the AIMS, SAS, and BARS
    Other Outcomes:
    • Change from baseline to endpoint for P-QLES-Q
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 49 endpoint events
    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 Yes
    E.6.13.1Other scope of the trial description
    long-term safety and tolerability
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    India
    Malaysia
    Philippines
    Romania
    Russian Federation
    Taiwan
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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 Yes
    F.1.1Number of subjects for this age range: 138
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 120
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 138
    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 Phase 3 or who are discontinued/withdrawn during Phase 3 and meet at least 1 of the criteria for exacerbation of psychotic symptoms/impending relapse, may be offered entry into an open-label safety trial of aripiprazole (31-09-267). Subjects are eligible to receive the OL study IP for up to one year.

    Any subject who does not enter the open-label study will be offered follow-up treatment (non-study medic suppl) for up to 12 weeks at the discretion of the investigator.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    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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